NCT06201065

FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib and Toripalimab Versus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Phase 3, Randomized Controlled and Double-blind Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Hepatic arterial infusion chemotherapy	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
DRUG	Lenvatinib	12 mg (or 8 mg) once daily (QD) oral dosing
DRUG	Toripalimab	240 mg iv.drip Q3W
DRUG	oxaliplatin , fluorouracil, and leucovorin	FOLFOX-HAIC

Timeline

• Start date: 2023-12-26
• Primary completion: 2025-07-26
• Completion: 2026-12-26
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: China