A Trial of Hepatic Arterial Infusion Combined With Bevacizumab and Sintilimab for Unresectable A-staged Hepatocellular Carcinoma in BCLC Classification (D-TRIPLET)
Summary
This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Bevacizumab and Sintilimab (Triplet-combined Therapy) for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the objective response rate (ORR RECIST 1.1) of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include the objective response rate (ORR mRECIST 1.1), duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for Unresectable A-staged Hepatocellular Carcinoma in BCLC classification.
Timeline
- Start
- 2022-03-16
- Primary completion
- 2023-01-01
- Completion
- 2023-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 2500 mg/m2 | Other |