RecruitingPhase 2NCT07157969

ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC

Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC


Sponsor

Peking Union Medical College Hospital

Enrollment

300 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment strategies for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed: immune checkpoint blockers combined with anti-VEGF drugs (which block blood vessel growth in tumors), either with or without additional tumor-targeting procedures like TACE (a form of chemotherapy delivered directly to the liver). **You may be eligible if...** - You are 18 or older with confirmed hepatocellular carcinoma - Your cancer is at BCLC Stage B or C (intermediate to advanced) - You have at least one measurable tumor - Your liver function is relatively preserved (Child-Pugh A or B) - Your ECOG performance score is 0 or 1 - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You are a candidate for curative surgery or liver transplant - You are pregnant or breastfeeding - You have an active autoimmune disease - You have received local liver treatments (TACE, ablation, etc.) within the past 4 weeks - You had another cancer within the past 5 years 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

DRUGLenvatinib

≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily

DRUGPembrolizumab

200 mg intravenously every three weeks

DRUGAtezolizumab

1200 mg intravenously every three weeks

DRUGBevacizumab

15mg/kg intravenously every three weeks

DRUGCamrelizumab

200 mg intravenously every three weeks

DRUGApatinib

250mg once daily

PROCEDURETACE

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

PROCEDUREHAIC

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

PROCEDUREDEB-TACE

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

DRUGTislelizumab

200 mg intravenously every three weeks

DRUGSintilimab

200 mg intravenously every three weeks


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07157969


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