NCT04627363

HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

HAIC Synchronously Combined With Bevacizumab and Toripalimab First-line for Advanced Hepatocellular Carcinama

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Detailed description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Bevacizumab and Toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Conditions

• Hepatocellular Carcinoma
• Bevacizumab
• Liver Neoplasms
• Toripalimab
• Oxaliplatin

Interventions

Type	Name	Description
PROCEDURE	Hepatic arterial infusion chemotherapy	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks
DRUG	Bevacizumab	15mg/kg intravenously every 3 weeks
DRUG	Toripalimab	240mg intravenously every 3 weeks

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-30
• Completion: 2023-06-30
• First posted: 2020-11-13
• Last updated: 2020-11-13