Combining radiotherapy and immunotherapy for 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
This study is testing if combining radiation therapy with immunotherapy can help people with advanced liver cancer get better and qualify for a liver transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, immunotherapy, radiation |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Trial ID | NCT06725121 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining locoregional therapy, specifically stereotactic body radiotherapy (SBRT) or Yttrium-90 (Y-90), with immunotherapy using Atezolizumab and Bevacizumab in patients with advanced hepatocellular carcinoma (HCC) and macrovascular invasion. Participants will undergo a biopsy, receive the combined treatment, and may be referred for liver transplantation if eligible. The study aims to determine the number of patients who achieve successful transplantation and assess their 5-year survival and recurrence-free survival rates. It is a pilot, open-label, single-arm study focused on integrating these therapies into the liver transplantation pathway.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with advanced hepatocellular carcinoma and macrovascular invasion who meet specific health criteria.
Not a fit: Patients with poorly differentiated HCC, extrahepatic disease, or contraindications to the therapies involved may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the number of patients with advanced liver cancer who are eligible for liver transplantation.
How similar studies have performed: While this approach is innovative, similar studies combining locoregional therapy with immunotherapy have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, Ontario and 1 other locations
- London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gonzalo Sapisochin, MD, PhD, MSc — University Health Network, Toronto
- Study coordinator: Clinical Research Manager
- Email: roxana.bucur@uhn.ca
- Phone: 437-772-4354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.