RecruitingPhase 3NCT06201065

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


Sponsor

Sun Yat-sen University

Enrollment

200 participants

Start Date

Dec 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding an immunotherapy drug (toripalimab) to a combination of chemotherapy delivered directly into the liver (FOLFOX-HAIC) plus a targeted therapy pill (lenvatinib) works better than the same regimen without immunotherapy for advanced liver cancer. **You may be eligible if...** - You have been diagnosed with advanced liver cancer (hepatocellular carcinoma, or HCC) - You have not received any prior cancer treatment - Your liver function is relatively well-preserved (Child-Pugh class A) - Your general health is good enough to handle treatment (ECOG score 0–2) - If you have hepatitis B, you are willing to take antiviral medication during the trial - You are 18 or older **You may NOT be eligible if...** - Your liver is failing (signs such as fluid buildup, bleeding from the gut, or confusion) - You have HIV - You have received an organ transplant - You have had significant gastrointestinal bleeding in the last 30 days - You have cancer that has spread to the brain - You have serious heart rhythm problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHepatic arterial infusion chemotherapy

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

DRUGLenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing

DRUGToripalimab

240 mg iv.drip Q3W

DRUGoxaliplatin , fluorouracil, and leucovorin

FOLFOX-HAIC


Locations(1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06201065


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