FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma
Summary
Study Design: This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments. Primary Objectives: To evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC. Secondary Objective(s): To evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC. To evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC. Exploratory Objective(s): Evaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .
Timeline
- Start
- 2025-09-25
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1120 mg | Intravenous |
| Subject | Leucovorin | Small molecule | 300 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 1500 mg/m2 | Other |