NCT06860490

HAIC Combined with Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

Sintilimab Plus Bevacizumab Biosimilar with or Without HAIC for Advanced Hepatocellular Carcinoma (TASK-03): a Multicenter, Randomized, Phase 2 Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.

Detailed description

This is a randomized, multicenter, phase II study to determine the efficacy and safety of Sintilimab plus bevacizumab biosimilar combined with hepatic arterial infusion chemotherapy (HAIC) compared to Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab will be administered by IV, 200 mg on day 1 of each 21 day cycle.
DRUG	Bevacizumab Biosimilar	Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.
PROCEDURE	HAIC	FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.

Timeline

• Start date: 2025-03-18
• Primary completion: 2027-03-10
• Completion: 2028-03-10
• First posted: 2025-03-06
• Last updated: 2025-03-26

Locations

1 site across 1 country: China