NCT04044313

HAIC Plus Lenvatinib and Toripalimab for Advanced HCC

Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Toripalimab for Advanced Hepatocellular Carcinoma： a Prospective, Single-arm Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Shi Ming · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)

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 programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC plus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Hepatic arterial infusion chemotherapy	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
DRUG	Lenvatinib	12 mg (or 8 mg) once daily (QD) oral dosing.
DRUG	Toripalimab	240mg intravenously every 3 weeks

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-02-01
• Completion: 2022-02-28
• First posted: 2019-08-05
• Last updated: 2023-06-12

Locations

1 site across 1 country: China