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NOT YET RECRUITING
NCT07522411
PHASE1/PHASE2

Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma

Sponsor: BinYong Liang

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. (1) Evaluate for some high-risk patients with resectable tumours, whether or not sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE reduces the risk of recurrence and improves the survival of patients. (2) Evaluate the safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE for the neoadjuvant therapy of resectable hepatocellular carcinoma.

Official title: Efficacy and Safety of Sequential FOLFOX-HAIC Followed by TACE Combined With Sintilimab Plus Bevacizumab as Neoadjuvant Therapy, Followed by Surgical Resection, Versus Direct Surgical Resection in Patients With Resectable Hepatocellular Carcinoma and High-Risk Recurrence Factors: A Single-Center, Open-Label, Two-Arm, Randomized Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-30

Completion Date

2028-02

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

FOLFOX regimen

oxaliplatin 85 mg/m² intra-arterial infusion over 2 hours; leucovorin calcium 200 mg/m² intra-arterial infusion over 2 hours; 5-fluorouracil 400 mg/m² intra-arterial bolus followed by 2400 mg/m² continuous intra-arterial infusion over 46 hours

DRUG

Immunotherapy

sintilimab (200 mg intravenous infusion, q3w)

DRUG

targeted therapy

bevacizumab (15 mg/kg intravenous infusion, q3w)

DEVICE

cTACE

conventional transarterial chemoembolization