Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Sponsor
Ze-yang Ding, MD
Study ID
NCT05713994
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

  • HAIC — PROCEDURE
    administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
  • Bevacizumab plus Atezolizumab — DRUG
    Bevacizumab (15mg/kg, q3w) plus Atezolizumab (1200 mg, q3w)
  • Bevacizumab Biosimilar IBI305 plus sintilimab — DRUG
    Bevacizumab Biosimilar IBI305 (15mg/kg, q3w), and sintilimab (200 mg, q3w)
  • Lenvatinib — DRUG
    8mg; p.o.; q.d.
  • Sorafenib — DRUG
    400mg; p.o. bid
  • Donafenib — DRUG
    200mg; p.o. bid
  • Regorafenib — DRUG
    160 mg; p.o.; q.d.
  • apatinib plus camrelizumab — DRUG
    Apatinib(250 mg; p.o.; q. d.); camrelizumab (200 mg; iv drip; q2w)
  • Anti-PD-1 monoclonal antibody — DRUG
    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).

Study Details

This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor/ anti-VEGF antibody, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

Key Dates

Start date
May 19, 2020
Status verified
Mar 2025
Primary completion
Jun 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
300 participants (estimated)

Arms

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