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

Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06335927
Study type Interventional
Source Fudan University
Contact Lu Wang, M.D.
Phone +8618121299357
Email w.lr@hotmail.com
Status Recruiting
Phase Phase 2
Start date May 11, 2023
Completion date May 10, 2026
View Details
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