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RECRUITING
NCT06201065
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China