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Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllUniversity Health Network, Toronto
NCT06725121 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if locoregional therapy and immunotherapy can be used together to help patients with hepatocellular carcinoma (HCC) and macrovascular invasion achieve liver transplantation. The main questions it aims to answer are: * How many patients will achieve transplant with this treatment strategy? * What will the 5-year survival and recurrence-free survival rates be for these patients? Participants will: * Undergo a biopsy of the tumor. * Receive locoregional therapy (SBRT or Y90) followed by immunotherapy (atezolizumab and bevacizumab) 2 to 6 weeks later, for a maximum of 9 months. * Be referred for a liver transplant and undergo the procedure if deemed eligible and safe. * If applicable, be followed for five years post-transplant with regular data collection.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-70 * Weight \> 30 kg * Child Pugh Turcotte score A5 to B7 * Macrovascular invasion (Vp1-3) * Total tumour volume \< 350 cm3 * Alpha Fetoprotein \< 5000 ng/mL * No extrahepatic disease * No other contraindications to undergo a LT * Eastern Cooperative Oncology Group (ECOG) score 0-1 * Capable to provide inform consent * Radiological and histological confirmation of hepatocellular carcinoma Exclusion Criteria: * Poorly differentiated HCC * Prior therapy for hepatocellular carcinoma other than liver resection or ablation * Portal vein tumor thrombus extending beyond main portal vein * Obesity class III (BMI ≥ 40 kg/m2) * Contraindications for radiotherapy (Y90 or SBRT) or AtezoBev
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What it tests

  • Atezolizumab & Bevacizumab
  • Yttrium-90 (Y-90)
  • Stereotactic body radiotherapy (SBRT)
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Where

2 sites
London Health Sciences Centre
London, Canada
Toronto General Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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