A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer.

开始日期2024-05-01

申办/合作机构

Tianjin Medical University Cancer Institute and Hospital

NCT06333821 / Not yet recruiting临床3期

A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.
The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.

开始日期2024-04-01

申办/合作机构

百泰生物药业有限公司

NCT06343116 / Not yet recruiting临床3期

Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine/Tipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer

This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).

开始日期2024-04-01

申办/合作机构

百泰生物药业有限公司

100 项与尼妥珠单抗相关的临床结果

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100 项与尼妥珠单抗相关的转化医学

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100 项与尼妥珠单抗相关的专利（医药）

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项与尼妥珠单抗相关的文献（医药）

2024-04-01·Acta Biomaterialia

A nanomedicine composed of polymer-ss-DOX and polymer-Ce6 prodrugs with monoclonal antibody targeting effect for anti-tumor chemo-photodynamic synergetic therapy

Article

作者: Sun, Xingwei ; Ni, Peihong ; He, Jinlin ; Yu, Liang ; Zhang, Mingzu

Anticancer drugs used for systemic chemotherapy often exhibit off-target toxicity and uncontrolled drug release due to their lack of targeting. To improve the bioavailability of drugs and reduce side effects, we have developed a mixed micelle of nanomedicine composed of two prodrugs with surface modified monoclonal antibody for cancer therapy. In this system, Nimotuzumab was used as targeting ligands of the mixed micelles (named as DCMMs) that is composed of polymer-doxorubicin prodrug (abbreviated as PEG-b-P(GMA-ss-DOX)) and maleimide polyethylene glycol-chlorin e6 (abbreviated as Mal-PEG-Ce6). The mixed micelles modified with Nimotuzumab (named as NTZ-DCMMs) bind to overexpressed EGFR receptors on Hepatoma-22 (H22) cells. Disulfide bonds in PEG-b-P(GMA-ss-DOX) are disrupted in tumor microenvironment, inducing the reduction-responsive release of DOX and leading to tumor cell apoptosis. Simultaneously, Chlorin e6 (Ce6) produced plenty of singlet oxygen (¹O₂) under laser irradiation to kill tumor cells. In vivo biological distribution and antineoplastic effect experiments demonstrate that NTZ-DCMMs enhanced drug enrichment at tumor sites through targeting function of antibody, dramatically suppressing tumor growth and mitigating cardiotoxicity of drugs. All results prove that NTZ-DCMMs have the ability to actively target H22 cells and quickly respond to tumor microenvironment, which is expected to become an intelligent and multifunctional drug delivery carrier for efficient chemotherapy and photodynamic therapy of hepatoma. STATEMENT OF SIGNIFICANCE: Anticancer drugs used for systemic chemotherapy often exhibit off-target toxicity due to their lack of targeting. Therefore, it's necessary to develop effective, targeted, and collaborative treatment strategies. We construct a mixed micelle of nanomedicine based on two polymer prodrugs and modified with monoclonal antibody on surface for cancer therapy. Under the tumor cell microenvironment, the disulfide bonds of polymer-ss-DOX were broken, effectively triggering DOX release. The photosensitizer Ce6 could generate a large amount of ROS under light, which synergistically promotes tumor cell apoptosis. By coupling antibodies to the hydrophilic segments of polymer micelles, drugs can be specifically delivered. Compared with monotherapy, the combination of chemotherapy and photodynamic therapy can significantly enhance the therapeutic effect of liver cancer.

2024-03-01·Journal of Nuclear Medicine

Effectiveness of²²⁵Ac-Labeled Anti-EGFR Radioimmunoconjugate in EGFR-Positive Kirsten Rat Sarcoma Viral Oncogene and BRAF Mutant Colorectal Cancer Models

Article

作者: Tikum, Anjong Florence ; Njotu, Fabrice Ngoh ; Babeker, Hanan ; Doroudi, Alireza ; Fonge, Humphrey ; Ketchemen, Jessica P ; Nambisan, Anand K

Eighty percent of colorectal cancers (CRCs) overexpress epidermal growth factor receptor (EGFR). Kirsten rat sarcoma viral oncogene (KRAS) mutations are present in 40% of CRCs and drive de novo resistance to anti-EGFR drugs. BRAF oncogene is mutated in 7%-10% of CRCs, with even worse prognosis. We have evaluated the effectiveness of [²²⁵Ac]Ac-macropa-nimotuzumab in KRAS mutant and in KRAS wild-type and BRAF^V600E mutant EGFR-positive CRC cells in vitro and in vivo. Anti-CD20 [²²⁵Ac]Ac-macropa-rituximab was developed and used as a nonspecific radioimmunoconjugate. Methods: Anti-EGFR antibody nimotuzumab was radiolabeled with ²²⁵Ac via an 18-membered macrocyclic chelator p-SCN-macropa. The immunoconjugate was characterized using flow cytometry, radioligand binding assay, and high-performance liquid chromatography, and internalization was studied using live-cell imaging. In vitro cytotoxicity was evaluated in 2-dimensional monolayer EGFR-positive KRAS mutant DLD-1, SW620, and SNU-C2B; in KRAS wild-type and BRAF^V600E mutant HT-29 CRC cell lines; and in 3-dimensional spheroids. Dosimetry was studied in healthy mice. The in vivo efficacy of [²²⁵Ac]Ac-macropa-nimotuzumab was evaluated in mice bearing DLD-1, SW620, and HT-29 xenografts after treatment with 3 doses of 13 kBq/dose administered 10 d apart. Results: In all cell lines, in vitro studies showed enhanced cytotoxicity of [²²⁵Ac]Ac-macropa-nimotuzumab compared with nimotuzumab and controls. The inhibitory concentration of 50% in the DLD-1 cell line was 1.8 nM for [²²⁵Ac]Ac-macropa-nimotuzumab versus 84.1 nM for nimotuzumab. Similarly, the inhibitory concentration of 50% was up to 79-fold lower for [²²⁵Ac]Ac-macropa-nimotuzumab than for nimotuzumab in KRAS mutant SNU-C2B and SW620 and in KRAS wild-type and BRAF^V600E mutant HT-29 CRC cell lines. A similar trend was observed for 3-dimensional spheroids. Internalization peaked 24-48 h after incubation and depended on EGFR expression. In the [²²⁵Ac]Ac-macropa-nimotuzumab group, 3 of 7 mice bearing DLD-1 tumors had complete remission. Median survival was 40 and 34 d for mice treated with phosphate-buffered saline and [²²⁵Ac]Ac-macropa-rituximab (control), respectively, whereas it was not reached for the [²²⁵Ac]Ac-macropa-nimotuzumab group (>90 d). Similarly, median survival of mice bearing HT-29 xenografts was 16 and 12.5 d for those treated with [²²⁵Ac]Ac-macropa-rituximab and phosphate-buffered saline, respectively, and was not reached for those treated with [²²⁵Ac]Ac-macropa-nimotuzumab (>90 d). One of 7 mice bearing HT-29 xenografts and treated using [²²⁵Ac]Ac-macropa-nimotuzumab had complete remission. Compared with untreated mice, [²²⁵Ac]Ac-macropa-nimotuzumab more than doubled (16 vs. 41 d) the median survival of mice bearing SW620 xenografts. Conclusion: [²²⁵Ac]Ac-macropa-nimotuzumab is effective against KRAS mutant and BRAF^V600E mutant CRC models.

2024-02-15·Current Cancer Drug Targets

Efficacy and Safety of Nimotuzumab in Combination with Radiotherapy or Chemoradiotherapy for Local Advanced Head and Neck Cancer: A Systematic Review and Meta-analysis

Article

作者: Ou, Xiaomin ; Qiao, Qiao ; Zhang, Peng ; Hu, Man ; Han, Yaqian ; Yi, Junlin ; Guo, Ruyuan ; Li, Jingao ; Zhang, Ximei ; Feng, Mei ; Tu, Wenyong ; Wu, Hui ; Jiang, Xin ; Zheng, Baomin ; He, Meilin

Background:The present meta-analysis aimed to evaluate the efficacy and safety of adding nimotuzumab to radiotherapy (RT) or chemoradiotherapy (CRT).Methods:Prospective randomized controlled studies at EMBASE, PubMed, and the Cochrane Library from January 1, 2010, to October 1, 2022, were searched. Data on the overall survival (OS), progress-free survival (PFS), disease-free survival (DFS), complete response rate (CRR), objective response rate (ORR), and all grade adverse events were collected from the enrolled publications. OS was the primary measurement indicator. Pooled analysis was performed with relative risks (RRs), hazard risks (HRs), and their corresponding 95% confidence intervals (CIs) in the software Stata SE 16.0.Results:Six randomized controlled studies were included in the analysis of the overall pooled effect. As compared to the control group, the nimotuzumab intervention group exhibited improved OS by 21% (pooled HR=0.79,95% CI: 0.64-0.98, P=0.028), along with PFS up to 31% (HR=0.69, 95% CI: 0.55-0.86, P=0.001) and DFS up to 29% (HR=0.71, 95% CI: 0.56-0.91, P=0.006), increased CRR as 50% (RR=1.50, 95%CI:1.09-2.04; P=0.012), and ORR as 35% (RR=1.35, 95%- CI:1.04-1.73; P=0.022). Regarding safety, nimotuzumab in combination with RT or CRT did not increase the incidence of all grade adverse events (pooled-RD=-1.27, 95%CI:-2.78-0.23, P=0.099).Conclusion:The present meta-analysis has demonstrated that nimotuzumab, in combination with RT or CRT, could provide survival benefits and increase response rates. Its safety profile has been found to be controllable.

项与尼妥珠单抗相关的新闻（医药）

2024-04-25

·BiG生物创新社

ASCO 2024丨这些中国临床专家，将分享最新重磅研究

2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜教授，上海交通大学附属胸科医院口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军教授，北京大学肿瘤医院快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明教授，中山大学肿瘤防治中心 BiG 十周年预告本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？

ASCO会议临床结果

2024-04-01

·医药观澜

2024年第一季度，NMPA批准超30款新药/新适应症（附PDF下载）

▎药明康德内容团队报道根据中国国家药监局（NMPA）官网批件信息统计：2024年第一季度共有17款新药*在中国首次获批上市，其中包括了6款1类新药，来自科济药业、科州制药、恒瑞医药、四环医药、罗氏（Roche）、卫材（Eisai）/渤健（Biogen）；同时也有18款新药在中国实现了新适应症或新剂型获批上市。在我们统计的超30个新药/新适应症的获批信息中，抗肿瘤适应症占比最多，其次是罕见病适应症；同时，阿尔茨海默病、偏头痛等神经系统疾病也迎来多款新疗法。本文就让我们来一起看看第一季度获批的新药有哪些亮点。（*新药统计范围包括化学药品1类和5.1类、治疗用生物制品1类和3.1类，未统计疫苗类产品）扫描下方二维码，可获取《2024年第一季度中国获批上市新药》完整数据PDF文件。亮点一、10多款抗肿瘤新药获批，单抗药物占55%从适应症来看，第一季度获批新药中，抗肿瘤新药占比最多，共有10多款新药获批用于治疗不同类型的肿瘤，包括肝细胞癌、胃癌、非小细胞肺癌、乳腺癌、胰腺癌、头颈部肿瘤、胆道癌、NTRK融合儿童实体瘤、多发性骨髓瘤、黑色素瘤等。这些新药的分子类型包括单抗、小分子药物和CAR-T细胞疗法。其中，有4款抗PD-1/L1单抗产品获批新适应症。包括：百济神州的替雷利珠单抗在中国获批第12项适应症，单药用于肝细胞癌患者的一线治疗；君实生物的特瑞普利单抗在中国获批第7项适应症，用于可切除非小细胞肺癌围手术期治疗；默沙东（MSD）的帕博利珠单抗在中国获批第13个适应症，用于局部晚期或转移性胆道癌患者的一线治疗；基石药业的舒格利单抗在中国获批第5项适应症，用于胃及胃食管结合部腺癌的一线治疗。PD-1/L1抑制剂之外，还有一些其它抗体药物获批肿瘤适应症。例如，罗氏的抗HER2单抗复方制剂帕妥珠曲妥珠单抗注射液（皮下注射），获批用于治疗成人HER2阳性早期和转移性乳腺癌患者。与标准静脉给药的数小时相比，这款皮下注射的复方制剂可以实现5~8分钟完成治疗，为乳腺癌患者带来更为便捷的治疗选择。此外，百泰生物的抗EGFR单抗尼妥珠单抗在中国获批头颈部鳞癌新适应症，该药此前已经在中国获批治疗鼻咽癌、胰腺癌。同时，第一季度还有4款小分子新药收获了肿瘤适应症。其中，科州制药的MEK抑制剂妥拉美替尼为首次获批，用于含PD-1/PD-L1治疗失败的NRAS突变的晚期黑色素瘤患者。此外，还有3款小分子新药获批新适应症，分别为：百时美施贵宝公司的注射用紫杉醇（白蛋白结合型），获批用于转移性胰腺癌的一线治疗；齐鲁制药的ALK/ROS1抑制剂伊鲁阿克，获批一线治疗ALK阳性非小细胞肺癌，将适应症拓展至覆盖全部ALK阳性局部晚期或转移性非小细胞肺癌者人群；罗氏的TRK/ROS1酪氨酸激酶抑制剂恩曲替尼胶囊，获批治疗1月龄以上NTRK融合儿童实体瘤患者，该产品具有中枢神经系统（CNS）活性，在针对颅外实体瘤或原发性CNS肿瘤儿童患者时表现出快速和持久的缓解。在细胞与基因疗法领域，科济药业靶向BCMA的自体CAR-T细胞疗法泽沃基奥仑赛注射液在中国获批上市，用于治疗经过至少3线治疗后进展的复发或难治性多发性骨髓瘤成人患者。公开资料显示，这也是中国获批上市的第5款CAR-T细胞疗法，以及第二款靶向BCMA的CAR-T细胞治疗药物。亮点二、优先审评助力，多款罕见病新药获批在今年第一季度获批的新药中，有7款为罕见病新药，其中有5款罕见病新药是通过优先审评程序获批。罗氏的新型抗C5循环单克隆抗体可伐利单抗在中国获批用于未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人和青少年患者，患者可进行每四周一次皮下注射。PNH是一种罕见且危及生命的血液疾病。值得一提的是，本次获批是可伐利单抗在全球所有国家中的首次获批，同时这也是罗氏第一次在中国实现一款创新药的全球首发。另一款在中国实现全球首发的新药是勃林格殷格翰（Boehringer Ingelheim）的罕见皮肤病创新药佩索利单抗（皮下注射制剂），获批用于减少12岁及以上青少年和成人的泛发性脓疱型银屑病（GPP）发作。GPP是一种罕见的、复发性或持续发作的严重皮肤疾病。佩索利单抗是一款皮下注射的抗IL-36R单抗，其在临床研究中能显著降低GPP发作风险84%长达48周。武田（Takeda）有两款罕见病新药在中国获批上市。其一是注射用替度格鲁肽获批治疗短肠综合征（SBS）成人和1岁及以上儿童患者。根据武田新闻稿，这也是中国首个治疗短肠综合征的人胰高血糖素样肽2（GLP-2）类似物，它可以帮助患者提高剩余肠管的吸收功能，帮助降低甚至摆脱对肠外营养支持的依赖。其二是重组猪FⅧ（rpFⅧ）药物注射用舒索凝血素α，在中国获批用于获得性血友病A成人患者按需治疗和出血事件的控制。图片来源：123RF其它获批的罕见病新药还包括：Orphalan公司的铜离子络合剂四盐酸曲恩汀薄膜衣片，获批治疗成人、青少年和≥5岁儿童的威尔逊病（又称肝豆状核变性）。威尔逊病是一种罕见的慢性遗传病，因肝脏铜转运受损而可能威胁生命。诺贝仁制药（Nobelpharma）的铜吸收抑制剂醋酸锌片也在中国获批治疗威尔逊病。作为一种锌制剂，该药能阻止铜在肠道的吸收，并清除沉积于组织中的铜，可作为威尔逊病的治疗方式之一。苏庇医药（Sobi）的IL-1受体拮抗剂阿那白滞素注射液则在中国获批两项新适应症，分别用于治疗斯蒂尔病（Still’s disease）和冷吡啉相关周期性综合征（CAPS）。值得一提的是，这两种罕见病均已经在中国被纳入《第二批罕见病目录》。亮点三：阿尔茨海默病、偏头痛等疾病迎来新疗法除了抗肿瘤和罕见病新药，第一季度在中国获批上市的新药还包括了至少4款精神/神经系统新药，适应症涵盖多动症、偏头痛、阿尔茨海默病等。其中，有两款CGRP受体拮抗剂在中国获批上市，分别为：礼来（Eli Lilly and Company）公司的加卡奈珠单抗注射液，获批用于成人偏头痛的预防性治疗；辉瑞公司（Pfizer）的瑞美吉泮口崩片，获批用于成年人有或无先兆偏头痛的急性治疗。偏头痛是一种失能性神经疾病，被世界卫生组织（WHO）列为10种致残性“最强”的内科疾病之一。CGRP信号通路已经成为治疗偏头痛的热门靶点。本次这两款新药相继在中国获批，无疑为中国的偏头痛患者带来福音。阿尔茨海默病领域也迎来好消息。卫材/渤健的仑卡奈单抗注射液在中国获批治疗早期阿尔茨海默病（AD）。仑卡奈单抗是一款抗可溶性β淀粉样蛋白（Aβ）单克隆抗体，也是近年来靶向β淀粉样蛋白的第二款创新阿尔茨海默病疗法。这是一类“疾病修饰治疗”方法，其核心在于其对阿尔茨海默病的疾病发病机制进行干预，靶向清除患者大脑中过多的Aβ原纤维和Aβ斑块，从“源头”解决问题，而不仅仅是缓解症状或对症状进行管理。图片来源：123RF另外，祐儿医药的盐酸哌甲酯缓释干混悬剂获批用于治疗6岁及6岁以上注意缺陷多动障碍（ADHD，俗称多动症）。这是一款长效液体剂型，口服后45分钟起效、作用时间持续长达12小时，且口服溶液对于不愿意吞咽的儿童接受度更高。这是祐儿医药的盐酸哌甲酯获批的第二个剂型，该产品的缓释咀嚼片已于去年12月在中国获批上市。除了上述提到的新药，2024年第一季度还有一些其它新药、2类改良型新药/复方制剂、疫苗、生物类似药等在中国获批，限于篇幅，本文不再一一介绍。祝贺这些药物在中国获批上市，它们的到来将使更多患者拥有新的治疗选择。扫描下方二维码，可获取《2024年第一季度中国获批上市新药》完整数据PDF文件。（PDF文件包含新药、2类改良型新药/复方制剂、疫苗、生物类似药等）参考资料：[1]中国国家药监局（NMPA）官网. From https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html[2]各公司官方新闻稿本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

上市批准细胞疗法免疫疗法核酸药物疫苗

2024-03-27

·米内网

22个西药品牌厉害了！“神药”暴涨134%，石药、百济神州上榜，国产1类新药亮眼

精彩内容北上广是国内医药大市，米内网数据显示，2023年重点城市公立医院终端化学药（含生物药，下同）销售额超1800亿元，广州蝉联榜首、北京位列第二、上海回归第三。北上广三城第一畅销品类仍是抗肿瘤和免疫调节剂，随着集采、国谈持续推进，品牌TOP10不断洗牌，石药、齐鲁、复宏汉霖上榜，国产单抗类药物表现亮眼。2023年北上广公立医院终端化学药城市格局（单位：亿元）来源：米内网重点城市公立医院化学药终端竞争格局北京：降糖“神药”暴涨134%，石药一枝独秀米内网数据显示，2023年北京市公立医院终端化学药销售额超过210亿元，同比增长7.03%，创历史新高。从治疗领域上看，抗肿瘤和免疫调节剂为第一畅销品类，市场份额超过26%；其次为全身用抗感染药物、消化系统及代谢药、血液和造血系统药物，市场份额皆超过12%。北京市公立医院终端化学药年度销售趋势（单位：亿元）来源：米内网重点城市公立医院化学药终端竞争格局品牌TOP10销售额均超过1亿元，领军品牌“大换血”，默沙东的帕博利珠单抗注射液首次跻身榜首，销售额超过2亿元；赛诺菲的度普利尤单抗注射液首次位列第二、诺和诺德的司美格鲁肽注射液强势闯进前三。进口品牌霸屏，石药百克的聚乙二醇化重组人粒细胞刺激因子注射液是唯一上榜的国产品牌。2023年北京市公立医院终端化学药品牌TOP10来源：米内网重点城市公立医院化学药终端竞争格局从销售额增速上看，诺和诺德的司美格鲁肽注射液暴涨133.98%，石药百克的聚乙二醇化重组人粒细胞刺激因子注射液、百特的人血白蛋白、赛诺菲的度普利尤单抗注射液涨幅皆超过30%。诺和诺德的司美格鲁肽是一款GLP-1受体激动剂，全球已获批上市的适应症有2型糖尿病、减重。据诺和诺德财报，2023年司美格鲁肽全球销售额1458.11亿丹麦克朗（212亿美元），其中司美格鲁肽注射液Ozempic（2型糖尿病）收入957.18亿丹麦克朗（139亿美元），同比增长60%。在国内，司美格鲁肽于2021年获批用于治疗2型糖尿病，同年12月进入国家医保目录，市场进入快速放量阶段，后续减肥适应症获批将进一步带动销售。10个品牌中，阿托伐他汀钙片为第一批集采品种、注射用美罗培南为第七批集采品种，近年来市场持续承压。2023年立普妥（阿托伐他汀钙片）排名进一步跌至第五，销售额下滑5.32%。注射用美罗培南集采结果于2022年11月落地执行，石药欧意供应北京地区，2023年原研厂家日本住友销售额下滑18.88%，石药欧意销售额上涨43.37%。上海：9大品牌涨逾15%！复宏汉霖亮了米内网数据显示，2023年上海市公立医院终端化学药销售额接近180亿元，同比增长20.10%，但未超过疫情前水平。从治疗领域上看，抗肿瘤和免疫调节剂以超过26.72%的市场份额领跑；消化系统及代谢药、血液和造血系统药物分别位列第二、第三，市场份额皆超过13%。上海市公立医院终端化学药年度销售趋势（单位：亿元）来源：米内网重点城市公立医院化学药终端竞争格局品牌TOP10中，抗肿瘤和免疫调节剂有6个、血液和造血系统药物有3个、全身用抗感染药物有1个。盖立复的人血白蛋白蝉联榜首，西南药业的注射用头孢唑肟钠首次跃居第二，三生制药的重组人血小板生成素注射液蝉联第三。2023年上海市公立医院终端化学药品牌TOP10来源：米内网重点城市公立医院化学药终端竞争格局除了罗氏的注射用曲妥珠单抗销售额下滑1.13%，其余9个品牌销售额皆涨逾15%。其中，复宏汉霖的利妥昔单抗注射液暴涨98.88%，西南药业的注射用头孢唑肟钠大涨44.22%，齐鲁制药的贝伐珠单抗注射液大涨36.86%。对比北上广三城的公立医院终端化学药品牌TOP10，上海有5个国产品牌上榜，超过北京（1个）、广州（4个）。随着罗氏的贝伐珠单抗、利妥昔单抗先后跌出品牌TOP10榜单，复宏汉霖的利妥昔单抗、齐鲁制药的贝伐珠单抗于2023年成功替代原研药，取得一席之地。复宏汉霖的利妥昔单抗注射液最早于2019年获批上市，为国内首款生物类似药。米内网数据显示，2023年重点城市公立医院终端利妥昔单抗销售额超过13亿元，复宏汉霖占据42.88%市场份额，首次超越罗氏。此前国内已有复宏汉霖、信达生物、正大天晴的利妥昔单抗生物类似药获批上市，近日国药集团的利妥昔单抗注射液获批上市，成为国产第4家。广州：8款抗肿瘤药霸屏！石药、齐鲁、百济神州上榜米内网数据显示，2023年广州市公立医院终端化学药销售额超过220亿元，连续三年创历史新高，再次在北上广当中领跑。从治疗领域上看，抗肿瘤和免疫调节剂为第一畅销品类，市场份额高达35.87%；血液和造血系统药物位列第二，市场份额超过12%；全身用抗感染药物位列第三，占比11%。广州市公立医院终端化学药年度销售趋势（单位：亿元）来源：米内网重点城市公立医院化学药终端竞争格局品牌TOP10中，5个产品销售额超过2亿元。抗肿瘤药上榜产品多达8个，除了奥希替尼、多柔比星，其余抗肿瘤药产品均为单抗类药物。齐鲁制药的贝伐珠单抗注射液首次跻身榜首，阿斯利康的甲磺酸奥希替尼片位列第二，石药欧意的盐酸多柔比星脂质体注射液位列第三。2023年广州市公立医院终端化学药品牌TOP10来源：米内网重点城市公立医院化学药终端竞争格局从销售额变化上看，阿斯利康的甲磺酸奥希替尼片略微下滑0.52%，其在北京市公立医院终端销售额则大跌12.62%。百泰生物的尼妥珠单抗注射液、默沙东的帕博利珠单抗注射液涨幅皆超过50%，齐鲁制药的贝伐珠单抗注射液、百济神州的替雷利珠单抗注射液皆涨逾45%。石药集团在北上广三城的品牌TOP10中均占有一席之地，上榜北京、上海的产品皆是聚乙二醇化重组人粒细胞刺激因子注射液，而在广州上榜的产品是盐酸多柔比星脂质体注射液。盐酸多柔比星脂质体注射液属于纳米高端制剂，目前国内仅有5家企业获批生产，石药集团为该产品首家过评企业。令人欣喜的是，以往上榜的单抗类药物都是进口品牌，近年来随着国内药企创新能力提高，国产生物类似药、国产创新单抗类药物先后在榜单上取得一席之地。此次有2款国产创新单抗类药物首次上榜，具体为百济神州的替雷利珠单抗、百泰生物的尼妥珠单抗注射液。百泰生物的尼妥珠单抗是一款靶向表皮生长因子受体（EGFR）的人源化单克隆抗体，于2008年1月首次在国内获批用于治疗鼻咽癌，成为国内首个治疗恶性肿瘤的单抗类药物，2023年6月再获批联合吉西他滨治疗胰腺癌。该产品已于2017年进入国家医保目录，近年来市场规模不断创新高。数据来源：米内网数据库注：米内网重点城市公立医院化学药终端竞争格局是以北京、上海、广州等20个重点城市样本医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本城市样本医院数据库。上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

财报免疫疗法核酸药物带量采购

100 项与尼妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	尼妥珠单抗	L01XC	DB06192

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
胰腺癌	中国	百泰生物药业有限公司	2023-06-07
食管癌	古巴	-	2010-05-10
胶质瘤	古巴	CIMYM Biosciences, Inc.	2008-09-05
胶质母细胞瘤	乌克兰	Oncoscience AG	2008-04-13
鼻咽癌	中国	Biotech Pharmaceuticals Pty Ltd	2008-01-07
鼻咽肿瘤	印度	-	2006-07-21
头颈部肿瘤	古巴	Gilead Sciences, Inc.	2005-04-28

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃食管交界处腺癌	临床3期	中国	百泰生物药业有限公司	2023-07-24
胃腺癌	临床3期	中国	百泰生物药业有限公司	2023-07-24
头颈部鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2021-11-01
宫颈鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2016-05-10
宫颈癌	临床2期	阿尔及利亚	-	2015-10-28
头颈部局部晚期皮肤鳞状细胞癌	临床2期	巴西	Eurofarma Laboratórios SA	2013-11-01
食管癌	临床2期	巴西	Eurofarma Laboratórios SA	2009-01-21
食管癌	临床2期	巴西	Eurofarma Laboratórios SA	2009-01-21
宫颈癌	临床1期	阿尔及利亚	-	2015-10-28
胰腺癌	药物发现	加拿大	Oncoscience AG	2007-08-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04949503 (ASCO2023) 人工标引	N/A	局部晚期头颈部鳞状细胞癌	612	Control group (no nimotuzumab)ment	(積選餘選範廠簾夢窪範) = 築鹹願願鑰淵範顧積獵鑰餘壓繭簾糧憲廠壓簾 (鏇鹽艱醖憲觸憲廠夢積 ) 更多	积极	2023-05-31
				Control group (no nimotuzumab)	(積選餘選範廠簾夢窪範) = 鹽鑰鏇鑰鬱襯夢夢淵製鑰餘壓繭簾糧憲廠壓簾 (鏇鹽艱醖憲觸憲廠夢積 ) 更多
NCT02395016 (ASCO2022) 人工标引	临床3期	胰腺癌 KRAS Wild-type	92	gemcitabine 1000 mg/m2+Nimotuzumab 400 mg	(網構窪願餘襯網鬱範齋) = 積襯廠鑰鏇淵顧製築窪積網獵觸糧鏇壓鑰鹽蓋 (鬱膚繭糧淵衊選蓋憲夢 ) 更多	积极	2022-06-08
				gemcitabine 1000 mg/m2+placebo	(網構窪願餘襯網鬱範齋) = 選蓋淵積壓築選鬱夢鑰積網獵觸糧鏇壓鑰鹽蓋 (鬱膚繭糧淵衊選蓋憲夢 ) 更多
NCT01249352 (NICE, Pubmed) 人工标引	临床2期	食管癌一线	107	Chemoradiotherapy+nimotuzumab	(鏇觸餘網築構製窪衊鬱) = 鹽觸艱醖夢窪範憲鑰襯膚顧簾簾製壓鹽鹹鏇顧 (製夢願壓鬱壓襯鬱觸壓 ) 更多	积极	2018-01-01
				Chemoradiotherapy	(鏇觸餘網築構製窪衊鬱) = 築醖廠蓋積鏇襯簾鑰觸膚顧簾簾製壓鹽鹹鏇顧 (製夢願壓鬱壓襯鬱觸壓 ) 更多
NCT01463605 (Pubmed \| Chin J Cancer Res) 人工标引	临床2期	食管癌	46	Radiotherapy+nimotuzumab	襯簾選艱觸簾鹽繭鬱淵(糧獵鹹鏇壓齋蓋襯憲餘) = esophagitis 8.7%，pneumonitis 2.2%，thrombocytopenia 2.2% 膚憲範鏇觸顧窪積糧鏇 (蓋衊繭選觸獵鑰膚鬱鑰 ) 更多	积极	2021-02-28
NCT03388372 (Pubmed \| J Cancer) 人工标引	临床2期	EGFR突变胶质母细胞瘤一线 EGFR Positive	36	radiotherapy+temozolomide+nimotuzumab	(夢製夢鬱淵網簾憲襯網) = 夢構築憲選顧夢繭醖願鏇鑰構鬱顧繭顧淵鹽齋 (醖遞憲範繭糧蓋齋繭蓋 ) 更多	积极	2019-06-02
NCT02409186 (NXCEL1311, ASCO2022) 人工标引	临床3期	局部晚期食管鳞状细胞癌	200	chemo-radiotherapy+Nimotuzumab	(醖鹹獵願廠糧衊鬱積願) = 鹽選憲鑰鏇鹽遞願鹽餘繭鏇範艱構願獵艱壓壓 (觸鹹餘夢願網製顧選醖 ) 更多	积极	2022-06-02
				chemo-radiotherapy+placebo	(醖鹹獵願廠糧衊鬱積願) = 鹹鑰淵糧鏇衊構廠鏇鑰繭鏇範艱構願獵艱壓壓 (觸鹹餘夢願網製顧選醖 ) 更多
NCT01074021 (Pubmed) 人工标引	临床3期	鼻咽癌	62	Chemoradiotherapy+nimotuzumab	- 更多	优效	2018-01-01
				Chemoradiotherapy
NCT02577341 (Pubmed) 人工标引	临床2期	鳞状细胞肺癌	122	docetaxel+cisplatin+CCRT+Nimotuzumab	(鹽鹽願糧製憲範壓繭醖) = 衊鬱製遞築壓獵觸醖構醖選網壓網觸醖築蓋糧 (窪遞願鑰構鑰鬱鑰獵鹽 ) 更多	积极	2021-11-15
				docetaxel+cisplatin+CCRT	(鹽鹽願糧製憲範壓繭醖) = 製鏇構觸構夢窪鑰夢餘醖選網壓網觸醖築蓋糧 (窪遞願鑰構鑰鬱鑰獵鹽 ) 更多
NCT01074021 (ASCO2022) 人工标引	临床3期	晚期鼻咽癌一线	482	Nimotuzumab+chemoradiotherapy	(鏇齋夢鑰觸鏇簾遞淵憲) = 網選醖遞製膚鬱廠鬱願鏇蓋壓願夢醖製淵襯繭 (淵蓋鏇襯獵鹽齋遞積蓋 ) 更多	积极	2022-06-02
				chemoradiotherapy+placebo	(鏇齋夢鑰觸鏇簾遞淵憲) = 憲夢醖淵簾築鹽淵構鏇鏇蓋壓願夢醖製淵襯繭 (淵蓋鏇襯獵鹽齋遞積蓋 ) 更多
NCT00561691 (Pubmed \| J Neurooncol) 人工标引	临床3期	弥漫内生性脑桥神经胶质瘤	42	Radiotherapy+Nimotuzumab	(構襯糧繭範廠積遞淵夢) = 窪願壓夢鹽顧醖願製範淵網淵鏇遞鹹窪願衊構 (鑰醖襯鏇鏇憲衊範蓋夢 ) 更多	积极	2019-05-01