MedTrace Logo

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

NCT06201065 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-26
Primary Completion
2025-07-26
Completion
2026-12-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06201065 on ClinicalTrials.gov