NCT05978609

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma Non-resectable

Interventions

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

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2023-08-07
• Last updated: 2023-08-07

Locations

1 site across 1 country: China