NCT05348811

HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	HAIC combined with donafenib and sintilimab	HAIC- GEMOX regimen, gemcitabine 1000 mg/m2, oxaliplatin 85mg/m2 (if the maximum tumor diameter \> 10cm, the dose is 130mg/m2), the first day of each cycle (D1), Q3W. The maximum of 6 times. Sintilimab will be given on the first day of each cycle (D1). 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.The longest treatment time is 24 months. Donafenib was taken orally at 0.2 bid on an empty stomach (1 hour before or \> 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Donafenib treatment is initiated within 1 to 3 days of each HAIC treatment until toxicity is intolerable, the investigator determines disease progression, death, informed consent is withdrawn, new antitumor therapy is initiated, or treatment is discontinued for any other reason specified in the protocol.

Timeline

• Start date: 2022-06-13
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-04-27
• Last updated: 2026-01-06

Locations

1 site across 1 country: China