NCT07012798

FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

A Prospective, Single-arm, Single-center Phase II Clinical Study of Hepatic Artery Infusion Chemotherapy (FOLFOX) Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Durvalumab	1120mg, iv, q3w
DRUG	Bevacizumab	15mg/kg, iv, q3w
DRUG	HAIC of FOLFOX	HAIC (FOLFOX): oxaliplatin 100mg/m2, 4h, day 1 + leucovorin 300mg/m2, 2h, day 1 + fluorouracil 500mg/m2, 20min, day 1 + fluorouracil 1500mg/m2, 20h, q3w

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China