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

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

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

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-19

Primary Completion

2026-06-01

Completion

2027-06-30

Countries

• China

Study Locations