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
University Health Network, Toronto
48 participants
Dec 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria5
- 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
Interventions
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.
Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.
Dose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06725121