NCT04618367

HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

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

Summary

This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

Detailed description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and Sintilimab, 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 Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Conditions

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Sintilimab
• Portal Vein Tumor Thrombus

Interventions

Type	Name	Description
PROCEDURE	Hepatic arterial infusion chemotherapy	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks
DRUG	Lenvatinib	12 mg (or 8 mg) once daily (QD) oral dosing.
DRUG	Sintilimab	200mg intravenously every 3weeks

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-30
• Completion: 2022-12-30
• First posted: 2020-11-05
• Last updated: 2024-03-06

Locations

1 site across 1 country: China