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RECRUITING
NCT07157969
PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-02-19

Completion Date

2027-06-30

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

Lenvatinib

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

DRUG

Pembrolizumab

200 mg intravenously every three weeks

DRUG

Atezolizumab

1200 mg intravenously every three weeks

DRUG

Bevacizumab

15mg/kg intravenously every three weeks

DRUG

Camrelizumab

200 mg intravenously every three weeks

DRUG

Apatinib

250mg once daily

PROCEDURE

TACE

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

PROCEDURE

HAIC

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

PROCEDURE

DEB-TACE

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

DRUG

Tislelizumab

200 mg intravenously every three weeks

DRUG

Sintilimab

200 mg intravenously every three weeks

Locations (1)

Peking Union Medical College Hospital

Beijing, China