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.

Start Date01 Jan 2024

Sponsor / Collaborator

Fudan University

NCT03369041 / Active, not recruitingNot ApplicableIIT

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.

Start Date03 Feb 2016

Sponsor / Collaborator

Fédération Francophone de la Cancérologie Digestive

NCT02110953 / TerminatedPhase 1IIT

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.

Start Date29 Jan 2016

Sponsor / Collaborator

The Fox Chase Cancer Center

[+1]

100 Clinical Results associated with Irinotecan-eluting beads

100 Translational Medicine associated with Irinotecan-eluting beads

100 Patents (Medical) associated with Irinotecan-eluting beads

105

Literatures (Medical) associated with Irinotecan-eluting beads

01 Aug 2024·JACC: Heart Failure

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

Article

Author: 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. ; Mc Causland, Finnian R. ; Myhre, Peder ; Pfeffer, Marc A ; Vaduganathan, Muthiah ; Solomon, Scott D. ; Anand, Inder ; McGrath, Martina ; Claggett, Brian L. ; Pfeffer, Marc A. ; 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.

01 May 2024·European Journal of Heart Failure

Effects of sacubitril/valsartan according to polypharmacy status in PARAGON‐HF

Article

Author: Zile, Michael R. ; Claggett, Brian L. ; Rouleau, Jean L. ; Vaduganathan, Muthiah ; Yang, Mingming ; Matsumoto, Shingo ; Lefkowitz, Martin ; Shen, Li ; Vardeny, Orly ; Henderson, Alasdair ; Desai, Akshay S. ; McMurray, John J.V. ; Solomon, Scott D. ; Jhund, Pardeep S.

AimsPatients with heart failure (HF) and preserved ejection fraction (HFpEF) have a particularly high prevalence of comorbidities, often necessitating treatment with many medications. The aim of this study was to evaluate the association between polypharmacy status and outcomes in PARAGON‐HF.Methods and resultsIn this post hoc analysis, baseline medication status was available in 4793 of 4796 patients included in the primary analysis of PARAGON‐HF. The effects of sacubitril/valsartan, compared with valsartan, were assessed according to the number of medications at baseline: 683 non‐polypharmacy (<5 medications); 2750 polypharmacy (5–9 medications), and 1360 hyper‐polypharmacy (≥10 medications). The primary outcome was total HF hospitalizations and cardiovascular deaths. Patients with hyper‐polypharmacy were older, had more severe limitations due to HF (worse New York Heart Association class and Kansas City Cardiomyopathy Questionnaire scores), and had greater comorbidity. The non‐adjusted risk of the primary outcome was significantly higher in patients taking more medications, and similar trends were seen for HF hospitalization and cardiovascular and all‐cause death. The effect of sacubitril/valsartan versus valsartan on the primary outcome from the lowest to highest polypharmacy category was (as a rate ratio): 1.19 (0.76–1.85), 0.94 (0.77–1.15), and 0.77 (0.61–0.96) (pinteraction = 0.16). Treatment‐related adverse events were more common in patients in the higher polypharmacy categories but not more common with sacubitril/valsartan, versus valsartan, in any polypharmacy category.ConclusionsPolypharmacy is very common in patients with HFpEF, and those with polypharmacy have worse clinical status and a higher rate of non‐fatal and fatal outcomes. The benefit of sacubitril/valsartan was not diminished in patients taking a larger number of medications at baseline.

06 Dec 2023·Cureus

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy for Refractory Colorectal Liver Metastasis: A Systematic Review

Review

Author: Haridi, Merna ; Puvvada, Chaitanya S ; Soomro, Faiza H ; Sheikh, Aaiyat ; Fatima, Umaima ; Dayo, Sana M ; Gonzalez, Natalie A ; Osman, Hafsa A ; Yu, Ann Kashmer

Colorectal cancer and related mortality present a profound challenge in its management, even in this modern age. Even today, colorectal cancer-related deaths rank third in the world. Despite having multiple lines of chemotherapy, combined with radiotherapy and chemoembolization techniques, after or before surgical resection, the five-year survival rate is approximately 20%. Drug-eluting bead, irinotecan (DEBIRI) is a new technique that involves embolization of the feeding vessels to the tumour and delivering irinotecan for its chemotherapeutic effects. A significant amount of literature compares DEBIRI as an adjunct to various lines of chemotherapy. However, so far, not much data are available on DEBIRI as a singular treatment for those patients who have had multiple chemotherapies and still progressing and are not fit for liver resection. In this systematic review, we aim to highlight and bring together the results of those studies that focused on this specific patient group. A systematic search of the literature involving three large databases (published between January 2017 and July 2022), excluding languages other than English, was conducted to identify articles documenting patients who had disease progression despite chemotherapy and were not fit for surgical resection. The level of evidence and the quality check were assessed by two independent reviewers, and consensus with the senior author resolved disagreements. Out of seven studies that met the final criteria, we found a pooled cohort of 302 patients. The mean age of the patients was 61.2 years, ranging from 40.7 to 84 years. The most commonly used DEBIRI beads were M1 (70-150 um) and M2 (100-300 um), but two studies reported the use of 40 um as well. The total number of DEBIRI treatments performed in our pooled cohort was 904. The majority of the studies reported only G1/G2 toxicities among the patients, with maximal toxicity of G4 in a few selected patients. The median overall survival in our pooled cohort was 19.52 months. The median progression-free survival in our data was 5.76 months. Our systematic review concludes that DEBIRI is undoubtedly a useful treatment modality with an acceptable toxicity profile. This treatment offers a good overall survival benefit for refractory colorectal liver metastasis.

News (Medical) associated with Irinotecan-eluting beads

29 Aug 2023

·www.prnewswire.com

Paragon Therapeutics Recognizes Key Milestones and Leadership Appointment for First Spinout, Apogee Therapeutics

Lead program, APG777, a novel subcutaneous half-life extended anti-IL-13 antibody, discovered by Paragon, enters first-in-human clinical trial Apogee Therapeutics' recently announced upsized IPO further demonstrates the value of best-in-class antibodies for immunological and inflammatory disorders Mark McKenna, former Chairman, President & CEO of Prometheus Biosciences, joins Apogee as Chairman of the Board of Directors WALTHAM, Mass., Aug. 29, 2023 /PRNewswire/ -- Paragon Therapeutics, Inc., a biotechnology company dedicated to discovering and developing best-in-class biologics for a range of diseases with high unmet need, today announced the achievement of key milestones by its first spinout company, Apogee Therapeutics (Nasdaq: APGE). Apogee recently announced upsizing of its initial public offering (IPO) with aggregate proceeds of $345 million, followed shortly by the initiation of the first-in-human clinical study of its lead asset, APG777—a potentially best-in-class biologic discovered by Paragon—in development for the treatment of moderate-to-severe atopic dermatitis (AD) and other inflammatory diseases. In preclinical studies, APG777 has demonstrated similar potency to current therapies, with a significantly longer half-life that could enable less frequent dosing. First-generation anti-IL-13 antibodies are dosed every two to four weeks. Extended biologic half-life can reduce dosing to once every two or three months—a potentially transformative change in the standard of care for people living with moderate-to-severe AD. "The success of Apogee's IPO and initiation of a clinical trial of its lead candidate are exciting milestones that underscore the value of our partnership for rapid advancement of potentially best-in-class biologics to market," said K. Evan Thompson, Ph.D., COO of Paragon. "The initiation of clinical evaluation highlights the strength of our partnership with Apogee and commitment to the accelerated development of improved treatment options for patients." Building on these important milestones, Apogee recently appointed industry veteran Mark McKenna, former Chairman, President and CEO of Prometheus Biosciences, as Chairman of the Board of Directors. McKenna will work closely with Apogee leadership to advise on market opportunities, business development, and bringing new therapeutics to patients based on his extensive experience and successful track record in the inflammation and immunology space. Apogee launched in December of 2022 with $169 million in funding and a pipeline of potentially best-in-class biologics addressing immune and inflammatory diseases originating from Paragon's discovery engine. With $345 million in proceeds from its upsized IPO and access to public markets, Apogee will continue clinical development of its biologics portfolio with the aim of overcoming the limitations of existing therapies for common inflammatory and immunology (I&I) diseases. About Paragon Therapeutics Paragon Therapeutics, Inc. is a biotechnology company leveraging cutting-edge science and technology to identify and propel best-in-class biologics into the clinic for a range of human diseases with high unmet needs. The company rapidly advances therapies through a range of opportunities, from new company creation and strategic partnerships to shaping programs in-house. Founded by Fairmount in 2021 as a joint venture with FairJourney Biologics, Paragon Therapeutics is based in Waltham, Mass. For more information, please visit . About Fairmount Fairmount Funds Management LLC is a Philadelphia-based investment firm dedicated to investing in promising new therapies pursued by biotechnology and life science companies. Media contact: Peg Rusconi, Verge Scientific Communications [email protected] SOURCE Paragon Therapeutics

IPOExecutive Change

100 Deals associated with Irinotecan-eluting beads

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R&D Status

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Indication	Country/Location	Organization	Date
Bile Duct Neoplasms	-	Singapore General Hospital Pte Ltd.	-
Colorectal Cancer	-	Singapore General Hospital Pte Ltd.	-
Glioma	-	Singapore General Hospital Pte Ltd.	-
Liver Cancer	-	Singapore General Hospital Pte Ltd.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01839877 (FFCD-1201 \| FFCD 1201, CTgov)	Phase 2	colon cancer liver metastasis	58	systemic FOLFOX+DEBIRI	bghyyidqvl(qjawpvlabr) = pinyoutbxe actynuwgxy (gpqahosxor, gtvdvbsbss - qcjwtponwm) View more	-	08 Oct 2024
ASCO2023	Not Applicable	Colorectal Liver Metastases	101	Irinotecan-eluting HepaSphere chemoembolization plus HAIC	(sxdymixeak) = 27.7% oicclpvowf (liigxirvkm ) View more	Positive	31 May 2023
NCT01839877 (FFCD-1201, Pubmed \| Med J Aust)	Phase 2	Colorectal Liver Metastases First line	58	DEBIRI plus mFOLFOX6	(kljxuotpcu) = fkqbpjzazr egaprhdkpm (tcddblbnpl ) View more	-	08 Jun 2020
NCT02015754 (CTgov)	Phase 2	Colorectal Liver Metastases	14	TACE+DEBIRI	siqikzpqck(yobtohhpdc) = uwfegqnydy wwqfbrfvqg (djrwrtayvk, drekafpzqr - aoefnlgkap) View more	-	22 Mar 2018
ASCO_GI2015	Phase 2	Colorectal Liver Metastases	-	DEBIRI	(hlfvwctqdb) = flhmugmgey jqftebqbdo (zjjozavsjv ) View more	Positive	20 Jan 2015
ASCO_GI2013	Not Applicable	Colorectal Liver Metastases Neoadjuvant	10	DEBIRI	gfgfbgjyww(tjkmqobwrd) = kdpbpqodhv zwofkablyf (cdjxemhebk ) View more	-	01 Feb 2013
ASCO_GI2012	Phase 3	Colorectal Liver Metastases	74	Polyvinyl alcohol microspheres loaded with irinotecan	(cohklomrpq) = ynuvfgxlrk leilnahiiu (fxkmtitsgy ) View more	Positive	01 Feb 2012
ASCO_GI2012	Phase 3	Colorectal Liver Metastases	74	Systemic chemotherapy	(cohklomrpq) = mpmazfjsas leilnahiiu (fxkmtitsgy ) View more	Positive	01 Feb 2012
ASCO2011	Not Applicable	Lung Cancer	16	drug-eluting beads (Segmental pulmonary arterial chemoembolization (SPACE) + RFA)	snlxgenhxf(tswbrdabhd) = 1 bronco-pleural fistula (5%) fnwiagoebq (polecpveyl ) View more	-	20 May 2011
PRECISION V (ASCO2010)	Not Applicable	Hepatocellular Carcinoma	212	PRECISION TACE with drug-eluting beads (DC Beads)	(wyzrwvuawr) = ztqnchhdos hipadvhokx (hqtaenazpb )	-	20 May 2010
PRECISION V (ASCO2010)	Not Applicable	Hepatocellular Carcinoma	212	PRECISION TACE with drug-eluting beads (conventional transarterial chemoembolization (cTACE))	(wyzrwvuawr) = xhkyswbels hipadvhokx (hqtaenazpb )	-	20 May 2010
ASCO2010	Not Applicable	Hepatocellular Carcinoma	56	DEB-TACE with epirubicin drug-eluting beads	(uynvpixrfm) = peoiurhcvg ccibfxrebm (bxqlacjiog ) View more	-	20 May 2010

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