NCT07157969

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-19
• Primary completion: 2026-06-01
• Completion: 2027-06-30
• First posted: 2025-09-05
• Last updated: 2025-12-01

Locations

1 site across 1 country: China