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NOT YET RECRUITING
NCT07618546
NA

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

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2026-05-25

Completion Date

2028-03-31

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Camrelizumab (anti-PD-1 inhibitor)

200 mg administered as intravenous infusion over approximately 30 minutes, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.

DRUG

Apatinib Mesylate Tablets

250 mg taken orally once daily, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.

DRUG

FOLFOX-HAIC

One cycle of hepatic arterial infusion (HAIC) using the FOLFOX regimen: Oxaliplatin 85 mg/m² over 0-2 hours, Leucovorin 400 mg/m² over 2-3 hours, 5-FU 400 mg/m² bolus at 3 hours, followed by 5-FU 2400 mg/m² continuous infusion for 44 hours. Administered once during the neoadjuvant phase.

OTHER

Surgery Alone

Patients undergo upfront radical hepatectomy without any perioperative systemic therapy. Postoperative follow-up is conducted according to routine clinical practice.