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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07157969
Phase
PHASE2
Status
Recruiting
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Conditions

  • HCC - Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    ≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
  • Pembrolizumab — DRUG
    200 mg intravenously every three weeks
  • Atezolizumab — DRUG
    1200 mg intravenously every three weeks
  • Bevacizumab — DRUG
    15mg/kg intravenously every three weeks
  • Camrelizumab — DRUG
    200 mg intravenously every three weeks
  • Apatinib — DRUG
    250mg once daily
  • TACE — PROCEDURE
    The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
  • HAIC — PROCEDURE
    The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
  • DEB-TACE — PROCEDURE
    The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
  • Tislelizumab — DRUG
    200 mg intravenously every three weeks
  • Sintilimab — DRUG
    200 mg intravenously every three weeks

Study Details

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.

Key Dates

Start date
Feb 19, 2025
Status verified
Feb 2025
Primary completion
Jun 1, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Immune checkpoint inhibitors combined with anti-VEGF drugs
    Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib.
  • Experimental: Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy
    Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC.

Primary Outcome Measure

ORR, objective response rate [ Time Frame: 12 months after the last subject is enrolled ]

Central Contacts

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