NCT06725121RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- Dec 2024
- Primary completion date
- Jun 2031
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06725121
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 48
- From Dec 2024 to the primary completion date, Jun 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy for hepatocellular carcinoma other than liver resection or ablation
- Contraindications for radiotherapy (Y90 or SBRT) or AtezoBev
Other
- Poorly differentiated HCC
- Portal vein tumor thrombus extending beyond main portal vein
- Obesity class III (BMI ≥ 40 kg/m2)
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.