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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • HCC - Hepatocellular Carcinoma

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.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618546 on ClinicalTrials.gov