drugset / Trial / NCT07522411
Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma
Phase 1/2
Not yet recruiting
100 enrolled
BinYong Liang
Beijing Bethune Charitable Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-30
- Primary completion
- 2027-12
- Completion
- 2028-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Other |