RecruitingPhase 2NCT05978609

Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer

Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies

Sponsor

West China Hospital

Enrollment

65 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Non-resectable

Summary

The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are: * Is this combined treatment protocol safe for these patients? * Is this combined treatment protocol effective in treating these patients? Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cadonilimab — an immunotherapy drug that blocks two immune checkpoints (PD-1 and CTLA-4) — combined with standard chemotherapy improves outcomes for people with advanced biliary tract cancers (cancers of the bile ducts, gallbladder, or liver drainage system). **You may be eligible if...** - You are 18–75 years old - You have confirmed advanced or metastatic biliary tract cancer (bile duct, gallbladder, or intrahepatic cancer) that cannot be removed with surgery - You have not received prior systemic chemotherapy for this cancer (adjuvant therapy completed more than 6 months ago is acceptable) - You are in good health (ECOG performance status 0–1) with adequate organ function - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have already received systemic treatment for your advanced cancer - You have active autoimmune disease - You have significant liver dysfunction or uncontrolled infections 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

DRUGCandonilimab

Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

DRUGCisplatin

Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

DRUGGemcitabine

gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT05978609

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