Combining radiotherapy and immunotherapy for advanced liver cancer before transplant
Official title: Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy (SBRT or Y90) and Atezolizumab Plus Bevacizumab Followed by Liver Transplantation - a Prospective Trial
Run by University Health Network, Toronto · NCT06725121 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, immunotherapy, radiation |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | December 2024 |
| Main results expected | June 2031 |
| Study ends | June 2034 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06725121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with advanced hepatocellular carcinoma and macrovascular invasion who meet specific health criteria.
✕Probably not a fit
Patients with poorly differentiated HCC, extrahepatic disease, or contraindications to the therapies involved may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies combining locoregional therapy with immunotherapy have shown promise, indicating potential for success.
Who can join: the full rules
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 it's running
-
Toronto General Hospital
Toronto, Ontario, Canada Recruiting -
London Health Sciences Centre
London, Ontario, Canada Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blood biomarkers to predict response to atezolizumab plus bevacizumab in hepatocellular carcinoma
This study tests whether blood-based biomarkers can predict which patients with advanced liver cancer will respond to first-line atezolizumab plus bevacizumab.
-
TIPS benefits for people with hepatocellular carcinoma taking Tecentriq (atezolizumab) plus Avastin (bevacizumab) as first-line therapy.
This study will try to see if placing a TIPS device helps people with advanced or unresectable hepatocellular carcinoma who are starting first-line treatment with Tecentriq plus Avastin.
-
FOLFOX chemotherapy with atezolizumab and bevacizumab after progression on atezolizumab plus bevacizumab for advanced liver cancer
This trial will test whether giving FOLFOX chemotherapy together with continued atezolizumab and bevacizumab helps people with advanced hepatocellular carcinoma whose cancer progressed on prior atezolizumab plus bevacizumab.
-
Preventing esophageal varices in liver cancer patients treated with specific medications
This study is testing whether treating liver cancer patients with specific medications can help prevent the worsening of esophageal varices and reduce the risk of bleeding.
-
Real-life experience with immunotherapy for liver cancer treatment
This study is testing new combinations of immunotherapy treatments for liver cancer to see how well they work and how safe they are for patients.
-
Evaluating RZ-001 with Valganciclovir and Atezolizumab/Bevacizumab for Liver Cancer
This study is testing a new combination treatment for advanced liver cancer to see if it is safe and effective for patients with a specific type of the disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.