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FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
Sponsor: Sun Yat-sen University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-12-26
Completion Date
2026-12-26
Last Updated
2024-01-11
Healthy Volunteers
No
Conditions
Interventions
Hepatic arterial infusion chemotherapy
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing
Toripalimab
240 mg iv.drip Q3W
oxaliplatin , fluorouracil, and leucovorin
FOLFOX-HAIC
Locations (1)
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China