RecruitingPhase 3NCT06172205

Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC

Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

262 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy delivery methods for advanced liver cancer (hepatocellular carcinoma): standard intravenous FOLFOX chemotherapy versus HAIC-FOLFOX (where the chemotherapy is delivered directly into the liver's blood supply through a catheter). Both groups also receive camrelizumab (immunotherapy) and apatinib (a drug that blocks tumor blood vessel growth). **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) at advanced stage (BCLC stage C) - Your liver function is rated Child-Pugh A or B (meaning the liver is still functioning reasonably well) - You have at least one measurable tumor - You have not yet received first-line targeted drug treatments such as sorafenib - You are in generally good health (ECOG 0-2) with expected survival of at least 12 weeks - If you have hepatitis B or C, you are receiving antiviral treatment **You may NOT be eligible if...** - You have received prior first-line systemic treatment for liver cancer - Your blood counts or organ function do not meet required levels - You are pregnant or breastfeeding 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

DRUGintravenous FOLFOX7 plus Camrelizumab and apatinib

Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days

DRUGHAIC-FOLFOX plus Camrelizumab and apatinib

2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days.


Locations(1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06172205


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