Spots Global Cancer Trial Database for HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

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Trial Identification

Brief Title: HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

Official Title: Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Donafenib and Sintilimab in First-line Treatment of Unresectable Intrahepatic Cholangiocarcinoma (ICC): a Prospective, Open-label, Phase II Study

Study ID: NCT05348811

Conditions

Cholangiocarcinoma

Interventions

HAIC combined with donafenib and sintilimab

Study Description

Brief Summary: To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC.

Detailed Description: Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of improving local drug concentration and reducing toxic and side effects. Currently, it is gradually used in the treatment of intrahepatic cholangiocarcinoma (ICC) with good safety and high objective response rate. Immunotherapy combined with targeted and chemotherapy was well tolerated. At present, anti-programmed cell death protein-1(PD-1) antibody combined with chemotherapy and targeted therapy for advanced biliary tract tumors has initially shown good safety and encouraging efficacy, which is worthy of further exploration. Therefore, this study aims to evaluate the efficacy and safety of HAIC (GEMOX regimen) combined with donafenib and sintilimab in unresectable ICC.