Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Sponsor
Tongji Hospital
Study ID
NCT05717738
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

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

Interventions

  • TACE — PROCEDURE
    Procedure of TACE is standardized.
  • Lenvatinib — DRUG
    8mg; p.o.; q.d.
  • Anti-PD-1 monoclonal antibody — DRUG
    Advanced HCC Patients treated with TKI plus anti-PD-1 monoclonal antibody as systemic therapy were recruited. Anti-PD-1 monoclonal antibodies include pembrolizumab (200 mg, q3w), nivolumab (3mg/kg, q2w), camrelizumab (200mg, q2w), tislelizumab (200mg, q3w), sintilimab (200 mg, q3w), or toripalimab (240mg, q3w).
  • Bevacizumab Biosimilar IBI305 plus sintilimab — DRUG
    Bevacizumab Biosimilar IBI305 (15mg/kg, q3w), and sintilimab (200 mg, q3w)
  • Bevacizumab plus Atezolizumab — DRUG
    Bevacizumab (15mg/kg, q3w) plus Atezolizumab (1200 mg, q3w)
  • apatinib plus camrelizumab — DRUG
    Apatinib(250 mg; p.o.; q. d.); camrelizumab (200 mg; iv drip; q2w)
  • Sorafenib — DRUG
    400mg; p.o. bid
  • Donafenib — DRUG
    200mg; p.o. bid
  • Regorafenib — DRUG
    160 mg; p.o.; q.d.

Study Details

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Key Dates

Start date
Jan 20, 2022
Status verified
Jun 2024
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: TACE-Len-ICI cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus lenvatinib (Len) and anti-PD-1 antibody as conversion therapy for downstaging.
  • Arm: TACE-A-T cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus bevacizumab (A) and atezolizumab (T) as conversion therapy for downstaging.
  • Arm: TACE-B-S cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus bevacizumab biosimilar (Byvasda, B) and Sintilimab (Tyvyt, S) antibody as conversion therapy for downstaging.
  • Arm: TACE-Apa-C cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus Apatinib (Apa) and Camrelizumab (C) antibody as conversion therapy for downstaging.
  • Arm: TACE-Sor-ICI cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus sorafenib (Sor) and anti-PD-1 antibody as conversion therapy for downstaging.
  • Arm: TACE-Don-ICI cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus donafenib (Don) and anti-PD-1 antibody as conversion therapy for downstaging.
  • Arm: TACE-Reg-ICI cohort
    Patients with advanced hepatocellular carcinoma who was initially evaluated unsuitable for the radical therapy and received combined TACE plus regorafenib (Reg) and anti-PD-1 antibody as conversion therapy for downstaging.

Primary Outcome Measure

Number of Patients Amendable to Curative Surgical Interventions [ Time Frame: from the date of first treatment to the date of last treatment, an average of 3 years ]

Central Contacts

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