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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |