RecruitingPhase 2NCT06438822

Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma

Second-line Treatment of PD-1 and CTLA-4 Blockade Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma: a Single-arm, Prospective Phase II Trial


Sponsor

West China Hospital

Enrollment

51 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced biliary tract cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination treatment for advanced bile duct cancer (cholangiocarcinoma) or gallbladder cancer that has stopped responding to standard chemotherapy. The regimen combines cadonilimab (an immunotherapy drug) with a modified chemotherapy called liposomal irinotecan plus leucovorin and fluorouracil. **You may be eligible if...** - You are between 18 and 75 years old with confirmed advanced bile duct or gallbladder cancer - Your cancer has progressed after or you could not tolerate gemcitabine-based chemotherapy - You have at least one measurable tumor by standard criteria - Your overall health is good (ECOG performance status 0–1) - Your blood counts, liver function, and kidney function meet study requirements **You may NOT be eligible if...** - You have had another cancer in the past 5 years (except treated skin cancer or cervical carcinoma in situ) - You have active HIV, active hepatitis B (high viral load), or hepatitis C - You have severe liver or kidney insufficiency or a recent heart attack - You have uncontrolled fluid around the lungs or in the abdomen (pleural effusion or ascites) - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil

cadonilimab at a dosage of 6 mg/kg on day 1 combined with intravenous liposomal irinotecan at a dosage of 70 mg/m2 for 90 min on day 1 plus leucovorin at a dosage of 400 mg/m2 for 30 min on day 1 and fluorouracil at a dosage of 2400 mg/m2 for 46 h every 2 weeks.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06438822


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