drugset / Trial / NCT07618546

A Multicenter, Randomized, Open-label, Controlled Study of HAIC Combined With Camrelizumab and Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma With High-risk Recurrence Factors

NCT07618546

Not yet recruiting 208 enrolled Henan Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year/2-year/3-year EFS rates.

Timeline

Start
2026-05-25
Primary completion
2027-03-31
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Other
Subject Oxaliplatin Small molecule 85 mg/m2 Other
Subject Rivoceranib Small molecule 250 mg Oral
Subject fluorouracil Small molecule 400 mg/m2 Other
Subject fluorouracil Small molecule 2400 mg/m2 Other