NCT06438822

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cadonilimab 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.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-08-30
• Completion: 2026-11-30
• First posted: 2024-06-03
• Last updated: 2025-05-07

Locations

1 site across 1 country: China