Overview

FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Status:
NOT_YET_RECRUITING

Trial end date:
2028-12-31

Target enrollment:

Participant gender:

Summary

This is a prospective, open-label, single-arm phase II study designed to evaluate the efficacy and safety of FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) in combination with donafenib and pucotenlimab as first-line treatment in patients with unresectable intrahepatic cholangiocarcinoma. Eligible patients will receive FOLFOX-HAIC administered every three weeks together with oral donafenib and intravenous pucotenlimab. Tumor response will be assessed according to RECIST v1.1. The primary objective of the study is to determine the objective response rate, and secondary objectives include progression-free survival, overall survival, disease control rate, and safety.

Phase:

PHASE2

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

donafenib
Fluorouracil
Folfox protocol
Leucovorin
Oxaliplatin