RecruitingPhase 3NCT07267806

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.


Sponsor

Linhui Peng

Enrollment

326 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of camrelizumab (an immunotherapy drug), apatinib (a targeted anti-cancer drug), and FOLFOX chemotherapy works better than camrelizumab plus apatinib alone for people with advanced liver cancer (hepatocellular carcinoma) that has not been treated with systemic therapy before. **You may be eligible if...** - You are 18 or older - You have advanced liver cancer (hepatocellular carcinoma) confirmed by tissue biopsy or imaging - Your cancer is at a stage where surgery or local treatments are no longer suitable, or your cancer has returned after those treatments - You have not received any systemic (whole-body) cancer treatment before - You have at least one measurable tumor on imaging - Your liver is functioning reasonably well (Child-Pugh A or better B) - You are in adequate physical condition (ECOG 0–2) **You may NOT be eligible if...** - You have a different type of liver tumor (e.g., bile duct cancer, mixed cancer types) - You have had a previous or concurrent other cancer in the past 5 years - You have significant fluid build-up in the abdomen (ascites) that cannot be controlled - You have had gastrointestinal bleeding, blood clots, or serious cardiovascular events in the past 6 months - You have active autoimmune disease, serious infections, or HIV - You have received prior anti-PD-1/PD-L1 immunotherapy or apatinib 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

DRUGInfusional mFOLFOX7 plus Camrelizumab and apatinib

Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

DRUGCamrelizumab and apatinib

Camrelizumab 200mg infusion on D1 forevery 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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NCT07267806


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