Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy (SBRT or Y90) and Atezolizumab Plus Bevacizumab Followed by Liver Transplantation - a Prospective Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Atezolizumab & Bevacizumab

Atezolizumab \& Bevacizumab will be initiated as part of the study, as per standard treatment protocol. Administration of Atezolizumab and Bevacizumab will be performed according to SOC in approx. 21-days intervals. Clinical follow up during treatment will be done as per SOC in medical and surgical oncology clinics at UHN.

DRUG

Yttrium-90 (Y-90)

Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.

RADIATION

Stereotactic body radiotherapy (SBRT)

Dose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.

Locations (2)

London Health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada