NCT06335927

HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC

Hepatic Arterial Infusion Chemotherapy Combined With Cadonilimab and Regorafenib as Second-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma. The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	HAIC-GEMOX+Cadonilimab+Regorafenib	HAIC-GEMOX: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles in combination with Cadonilimab (6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W)

Timeline

• Start date: 2023-05-11
• Primary completion: 2025-05-10
• Completion: 2026-05-10
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: China