TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC

Sponsor
Zhongda Hospital
Study ID
NCT05332496
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab — DRUG
    PD-1/PD-L1 inhibitors: atezolizumab, sintilimab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, toripalimab, durvalumab, penpulimab, and other ICIs; VEGF-TKI/bevacizumab: sorafenib, lenvatinib, donafenib, apatinib, anlotinib, bevacizumab/ bevacizumab biosimilar, and other anti-angiogenesis drugs; Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs only include marketed drugs but are not limited to HCC approval.
  • TACE — PROCEDURE
    TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

Study Details

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies in patients with Intermediate-stage hepatocellular carcinoma (HCC).

Key Dates

First listed
Apr 18, 2022
Start date
Dec 28, 2022
Status verified
Apr 2026
Primary completion
Jul 30, 2023
Completion
Sep 14, 2025

Study Design

Enrollment
941 participants (actual)

Arms

  • Arm: Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
    TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
  • Arm: Control group: TACE
    TACE monotherapy

Primary Outcome Measure

Progression free survival(PFS) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [ Time Frame: up to approximately 2 years ]

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