Irinotecan-eluting beads(Irinotecan-eluting beads) - 药物靶点：Top I_在研适应症：胆管癌，结直肠癌，胶质瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

DEBIRI、Irinotecan bead、PARAGON Bead

+ [2]

靶点

Top I

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤神经系统疾病消化系统疾病+ [1]

在研适应症

胆管癌结直肠癌胶质瘤+ [1]

非在研适应症-

原研机构

Singapore General Hospital Pte Ltd.

在研机构

Singapore General Hospital Pte Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C33H38N4O6

InChIKeyUWKQSNNFCGGAFS-XIFFEERXSA-N

CAS号97682-44-5

关联

7

项与 Irinotecan-eluting beads 相关的临床试验

NCT06177288

/ Not yet recruitingN/AIIT

A Prospective, Single-arm Clinical Study on the Efficacy and Safety of DEBIRI Combined With Systemic Chemotherapy and Bevacizumab for Unresectable Colorectal Cancer With Liver Metastases

To study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases.

开始日期2024-01-01

申办/合作机构

复旦大学

NCT03369041

/ Unknown statusN/AIIT

Study of the Practice of Debiri in France: Indications, Associations to Systemic Treatments, Efficiency, Tolerance - Prospective Practice Survey

In order to extract the profiles of patients receiving DEBIRI treatment at best, the investigators proposed the establishment of a national prospective cohort to collect information on the greatest number of patients treated with DEBIRI. This cohort will allow a better understanding of the effectiveness, tolerance, feasibility and differences of practices at national level for this approach. These data will assist in the development of clinical trials in situations that appear to be most promising in clinical practice.

开始日期2016-02-03

申办/合作机构

Fédération Francophone de la Cancérologie Digestive

NCT02110953

/ Terminated临床1期IIT

Phase I Study of Drug-Eluting Irinotecan Beads (DEBIRI) in Refractory Metastatic Colorectal Cancer With Liver-Only or Liver-Predominant Disease

This phase I trial studies the side effects and best dose of irinotecan-eluting beads in treating patients with colon or rectal cancer that has spread to the liver and does not respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. This treatment delivers the chemotherapy directly to the tumor area inside the liver instead of to the whole body as with systemic delivery of the drug. Irinotecan-eluting beads may work better that standard chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.

开始日期2016-01-29

申办/合作机构

The Fox Chase Cancer Center

[+1]

100 项与 Irinotecan-eluting beads 相关的临床结果

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100 项与 Irinotecan-eluting beads 相关的转化医学

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100 项与 Irinotecan-eluting beads 相关的专利（医药）

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108

项与 Irinotecan-eluting beads 相关的文献（医药）

2025-01-01·JACC: Heart Failure

Natriuretic Peptides, Kidney Function, and Clinical Outcomes in Heart Failure With Preserved Ejection Fraction

Article

作者: Mc Causland, Finnian R ; Desai, Akshay S ; Skali, Hicham ; Zile, Michael R ; Beldhuis, Iris ; Neuen, Brendon L ; McMurray, John J V ; McMurray, John JV. ; Claggett, Brian L ; Neuen, Brendon L. ; Myhre, Peder ; Mc Causland, Finnian R. ; Pfeffer, Marc A ; Vaduganathan, Muthiah ; Solomon, Scott D. ; Anand, Inder ; McGrath, Martina ; Pfeffer, Marc A. ; Claggett, Brian L. ; McMurray, John J.V. ; Solomon, Scott D ; Desai, Akshay S. ; Zile, Michael R.

BACKGROUNDN-terminal pro-B-type natriuretic peptides (NT-proBNPs) are guideline-recommended biomarkers for risk stratification in patients with heart failure. However, NT-proBNP levels are often elevated in chronic kidney disease, introducing uncertainty about their prognostic relevance in persons across a broad range of estimated glomerular filtration rate (eGFR).OBJECTIVESThe aim of this study was to assess the association of NT-proBNP with cardiovascular and mortality outcomes in patients with heart failure and mildly reduced or preserved ejection fraction, stratified by baseline kidney function.METHODSA pooled analysis was conducted of participants with NT-proBNP and eGFR measured at baseline in the I-PRESERVE (Irbesartan in Heart Failure and Preserved Ejection Fraction), TOPCAT (Americas region) (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function), PARAGON (Prospective Comparison of ARNI with ARB Global Outcomes in HF With Preserved Ejection Fraction), and DELIVER (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure) trials. The relationship between NT-proBNP and eGFR was assessed using piecewise linear regression. Using multivariable Cox and Poisson regression models, the association of NT-proBNP with outcomes across a range of eGFR was evaluated. The primary outcome was hospitalization for heart failure or cardiovascular death.RESULTSAmong 14,831 participants (mean age: 72.1 years; 50.3% female; mean eGFR: 63.3 mL/min/1.73 m², and median NT-proBNP: 840 pg/mL) followed up for a median 33.5 months, there were 3,092 primary outcomes. NT-proBNP levels increased by 9%, 8%, and 23% per 10 mL/min/1.73 m² lower eGFR in patients with baseline eGFR ≥60, 45-<60, and <45 mL/min/1.73 m², respectively (P for nonlinearity < 0.001). Each doubling in NT-proBNP was associated with a 37% relative increase in the primary outcome (HR: 1.37; 95% CI: 1.34-1.41), consistent across different eGFR categories (P for interaction = 0.42). For the same incidence of the primary outcome, NT-proBNP levels were approximately 2.5- to 3.5-fold lower in patients with eGFR <45 mL/min/1.73 m², compared with patients with eGFR ≥60 mL/min/1.73 m². Similar patterns were observed across all outcomes studied, including cardiovascular and noncardiovascular death.CONCLUSIONSThe same NT-proBNP concentration predicts a substantially higher absolute risk of adverse outcomes for people with heart failure and reduced kidney function, compared with those with preserved kidney function. These data call into question proposals for higher NT-proBNP references ranges in people with CKD, and suggest that reduced kidney function per se should not be a reason to disregard higher NT-proBNP levels.

2024-12-03·Circulation

Therapeutic Effects of Heart Failure Medical Therapies on Standardized Kidney Outcomes: Comprehensive Individual Participant–Level Analysis of 6 Randomized Clinical Trials

Article

作者: Neuen, Brendon L. ; Jhund, Pardeep S. ; Zannad, Faiez ; McCausland, Finnian R. ; Vaduganathan, Muthiah ; Lam, Carolyn S.P. ; Solomon, Scott D. ; Claggett, Brian L. ; Butt, Jawad H. ; Desai, Akshay S. ; Heerspink, Hiddo J.L. ; McMurray, John J.V. ; Pitt, Bertram ; Beldhuis, Iris E. ; Voors, Adriaan A. ; Packer, Milton ; Pfeffer, Marc A.

BACKGROUND:Kidney outcomes have been variably defined using nonstandardized composite end points in key heart failure trials, thus introducing complexity in their interpretation and cross-trial comparability. We examined the effects of steroidal mineralocorticoid receptor antagonists, the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan, and SGLT2 (sodium-glucose cotransporter-2) inhibitors on composite kidney end points using uniform definitions in 6 contemporary heart failure trials.METHODS:Individual participant–level data from trials of steroidal mineralocorticoid receptor antagonists (EMPHASIS-HF [Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure], TOPCAT [Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist] Americas), angiotensin receptor-neprilysin inhibitor (PARADIGM-HF [Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure], PARAGON-HF [Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor With Angiotensin-Receptor Blockers Global Outcomes in HF With Preserved Ejection Fraction]), and SGLT2 inhibitors (DAPA-HF [Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure], DELIVER [Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure]) were included. The standardized composite kidney end point was defined as a sustained decline (a reduction in estimated glomerular filtration rate (eGFR) confirmed by a subsequent measurement at least 30 days later) in eGFR by 40%, 50%, or 57%; end-stage kidney disease; or renal death. eGFR was recalculated in a standardized manner using the 2009 Chronic Kidney Disease Epidemiology Collaboration creatinine equation.RESULTS:Among 28 690 participants across the 6 trials (median age, 69 years [interquartile range, 62–76]; 9656 [33.7%] women), the proportion experiencing the composite kidney end point with a more stringent definition of a sustained decline in kidney function (eGFR threshold of 57%) ranged from 0.3% to 3.3%. The proportion of patients experiencing this end point with a less stringent definition (eGFR threshold of 40%) ranged from 1.0% to 10.0%. The steroidal mineralocorticoid receptor antagonists doubled the risk of the composite kidney end point when applying the least stringent definition compared with placebo, but these effects were less apparent and no longer significant with application of more stringent definitions. Angiotensin receptor-neprilysin inhibitor appeared to consistently reduce the occurrence of the composite kidney end points irrespective of the specific eGFR threshold applied. The potential benefits of SGLT2 inhibitors on the composite kidney end points appeared more apparent when defined by more stringent eGFR thresholds, although none of these effects individually were statistically significant.CONCLUSIONS:When applying standardized stringent kidney end point definitions, steroidal mineralocorticoid receptor antagonists, angiotensin receptor-neprilysin inhibitor, and SGLT2 inhibitors have either neutral or beneficial effects on kidney outcomes in heart failure. Applying less stringent definitions increased event rates but included acute declines in eGFR that might not ultimately reflect long-term effects on kidney disease progression.

2024-11-01·Journal of the American College of Cardiology

Systolic Blood Pressure and Pulse Pressure in Heart Failure

Article

作者: Zannad, Faiez ; Neuen, Brendon L ; McMurray, John J V ; Beldhuis, Iris E ; Anand, Inder S ; Mc Causland, Finnian R ; Pfeffer, Marc A ; Pitt, Bertram ; Claggett, Brian L ; Zile, Michael R ; Solomon, Scott D ; Vaduganathan, Muthiah ; Desai, Akshay S ; Jhund, Pardeep S ; Lu, Henri ; Kondo, Toru

BACKGROUNDHypertension is common in patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), and current guidelines recommend treating systolic blood pressure (SBP) to a target <130 mm Hg. However, data supporting treatment to this target are limited. Additionally, pulse pressure (PP), a marker of aortic stiffness, has been associated with increased risk of cardiovascular events, but its prognostic impact in HFpEF has not been extensively studied.OBJECTIVESThis study aimed to explore the impact of baseline SBP and PP on cardiovascular outcomes in patients with HFmrEF or HFpEF.METHODSThe I-PRESERVE (Irbesartan in Heart Failure With Preserved Ejection Fraction), TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist)-Americas, PARAGON-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor With Angiotensin-Receptor Blocker Global Outcomes in HF With Preserved Ejection Fraction), and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trials were global, randomized clinical trials testing irbesartan, spironolactone, sacubitril/valsartan, and dapagliflozin, respectively, against either a placebo or an active comparator (valsartan, in PARAGON-HF), in patients with heart failure and a left ventricular ejection fraction ≥40% (in DELIVER) or ≥45% (in the other trials). The relationship between continuous baseline SBP and PP, and the primary endpoint (first heart failure hospitalization or cardiovascular death) was analyzed with restricted cubic splines. We further evaluated the prognostic impact of SBP categories (<120, 120-129, 130-139, and ≥140 mm Hg) and PP quartiles on the primary endpoint.RESULTSA total of 16,950 patients (mean age 71 ± 9 years; 49% male; mean SBP 131 ± 15 mm Hg; mean PP 55 ± 14 mm Hg) were included. The relationship between SBP and the primary endpoint was J-shaped, with the lowest risk at 120 to 130 mm Hg. A similar pattern was found for PP, with the lowest risk at 50 to 60 mm Hg. The highest SBP category (reference: 120-129 mm Hg) and PP quartile (reference: 46-54 mm Hg) were associated with a higher risk of the primary outcome (HR: 1.22; 95% CI: 1.10-1.34 and HR: 1.22; 95% CI: 1.11-1.34, respectively). Higher PP was associated with greater cardiovascular risk, regardless of SBP.CONCLUSIONSOur analysis of a large pooled dataset from 4 clinical trials, including >16,900 patients with HFmrEF/HFpEF, indicates a J-shaped relationship between both SBP and PP and cardiovascular risk. The lowest risk was observed at SBP levels between 120 and 130 mm Hg and PP values between 50 and 60 mm Hg (I-PRESERVE [Irbesartan in Heart Failure With Preserved Systolic Function], NCT00095238; TOPCAT [Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist], NCT00094302; PARAGON-HF [Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction], NCT01920711; DELIVER [Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure], NCT03619213).

100 项与 Irinotecan-eluting beads 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX19	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
胆管癌	-	Singapore General Hospital Pte Ltd.	-
结直肠癌	-	Singapore General Hospital Pte Ltd.	-
胶质瘤	-	Singapore General Hospital Pte Ltd.	-
肝癌	-	Singapore General Hospital Pte Ltd.	-

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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


NCT01839877 (FFCD-1201 \| FFCD 1201, CTgov)	临床2期	结肠癌肝转移	58	systemic FOLFOX+DEBIRI	(網構鬱鹹鏇顧襯鑰餘夢) = 膚齋範簾餘鏇鏇窪築鑰簾選構憲鏇壓遞醖鏇壓 (壓構遞醖齋網糧餘繭鹹, 夢膚壓觸鬱範鬱窪窪艱 ~ 簾糧淵範築艱壓淵構衊) 更多	-	2024-10-08
ASCO2023	N/A	结直肠癌肝转移	101	Irinotecan-eluting HepaSphere chemoembolization plus HAIC	(餘繭艱窪繭選鏇顧窪醖) = 27.7% 觸餘糧繭餘範廠鏇範簾 (網積艱遞襯餘艱築衊獵 ) 更多	积极	2023-05-31
NCT01839877 (FFCD-1201, Pubmed \| Br J Cancer)	临床2期	结直肠癌肝转移一线	-	DEBIRI plus mFOLFOX6	(壓蓋艱餘壓簾襯襯鹽艱) = 夢獵鑰餘積夢糧鬱顧窪淵廠構鏇網觸鹽願選鹹 (繭範壓襯鑰廠蓋積襯窪 ) 更多	-	2020-08-18
NCT02015754 (CTgov)	临床2期	结直肠癌肝转移	14	TACE+DEBIRI	醖築窪鬱網顧齋鹹網齋(顧製襯窪觸鹹範憲艱窪) = 範艱襯積衊蓋蓋襯鹹廠鏇餘簾蓋鹽顧艱艱網範 (餘襯鏇衊遞獵艱願鹹積, 膚膚襯鑰餘衊窪艱夢廠 ~ 鏇衊選膚壓積選齋衊範) 更多	-	2018-03-22
ASCO_GI2015	临床2期	结直肠癌肝转移	-	DEBIRI	(顧築蓋鬱築蓋網齋鑰鏇) = 築壓蓋糧簾觸範膚夢夢夢鑰鑰壓鏇憲襯鹹艱觸 (齋繭構獵積憲淵襯蓋遞 ) 更多	积极	2015-01-20
ASCO_GI2013	N/A	结直肠癌肝转移新辅助	10	DEBIRI	簾鑰衊積積衊遞餘積鹽(積範鏇淵範餘艱積遞糧) = 網淵構廠鏇衊鑰壓願膚蓋襯醖衊壓襯襯廠構範 (構糧窪膚壓壓築鏇範蓋 ) 更多	-	2013-02-01
ASCO_GI2012	临床3期	结直肠癌肝转移	74	Polyvinyl alcohol microspheres loaded with irinotecan	壓遞顧壓膚鏇遞鬱壓積(膚蓋餘襯獵壓壓鬱獵範) = 鏇艱鏇顧襯簾廠憲膚製製遞繭製鏇醖膚窪膚淵 (醖衊憲網齋鬱鏇糧衊糧 ) 更多	积极	2012-02-01
ASCO_GI2012	临床3期	结直肠癌肝转移	74	Systemic chemotherapy	壓遞顧壓膚鏇遞鬱壓積(膚蓋餘襯獵壓壓鬱獵範) = 鑰壓窪範簾製繭淵製淵製遞繭製鏇醖膚窪膚淵 (醖衊憲網齋鬱鏇糧衊糧 ) 更多	积极	2012-02-01
ASCO2011	N/A	肺癌	16	drug-eluting beads (Segmental pulmonary arterial chemoembolization (SPACE) + RFA)	淵膚簾積願顧獵繭醖艱(簾艱選顧鏇觸選範艱獵) = 1 bronco-pleural fistula (5%) 鹹醖獵築選壓遞衊鑰衊 (遞構遞遞糧選窪鏇夢糧 ) 更多	-	2011-05-20
PRECISION V (ASCO2010)	N/A	肝细胞癌	212	PRECISION TACE with drug-eluting beads (DC Beads)	(範構願網淵醖願鏇廠廠) = 廠獵壓鬱鬱構艱製構膚衊鬱鬱積廠顧鹽積淵網 (築鹹齋襯壓鑰衊襯遞蓋 )	-	2010-05-20
PRECISION V (ASCO2010)	N/A	肝细胞癌	212	PRECISION TACE with drug-eluting beads (conventional transarterial chemoembolization (cTACE))	(範構願網淵醖願鏇廠廠) = 衊顧積鹹窪鏇襯鏇壓夢衊鬱鬱積廠顧鹽積淵網 (築鹹齋襯壓鑰衊襯遞蓋 )	-	2010-05-20
ASCO2010	N/A	肝细胞癌	56	DEB-TACE with epirubicin drug-eluting beads	(艱鹹夢衊築獵夢構繭築) = 壓製窪廠夢繭夢遞膚獵淵齋夢簾餘憲遞廠醖簾 (淵艱糧範艱鬱鏇網獵糧 ) 更多	-	2010-05-20