NCT06244225

HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma

An Exploratory Study to Evaluate the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine With Sintilimab and Donafenib for Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm exploratory clinical study to evaluate the efficacy and safety of HAIC in combination with Sintilimab and Donafenib in patients with BCLC-C stage who have not received prior systemic therapy

Detailed description

This trial is a single-arm, non-randomized and single-center clinical study of HAIC in combination with Sintilimab and Donafenib in the first-line treatment of BCLC-C stage unresectable hepatocellular carcinoma. The study is expected to include 38 subjects who meet the screening criteria to receive HAIC plus Sintilimab and Donafenib to evaluate the efficacy and safety of treatment, including time to progression（PFS）and overall survival（OS），etc.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Donafenib； Sintilimab； HAIC	Drug: Sintilimab Q3W 200mg IV d1, Q3W Drug: Donafenib 200 mg BID d1-21, Q3W other: HAIC Q3W Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2024-02-06
• Last updated: 2024-02-06

Locations

1 site across 1 country: China