NCT06725121 Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant
| NCT ID | NCT06725121 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-12 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2024-12 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Gonzalo Sapisochin, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT06725121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06725121 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06725121 currently recruiting?
Yes, NCT06725121 is actively recruiting participants. Contact the research team at roxana.bucur@uhn.ca for enrollment information.
Where is the NCT06725121 trial being conducted?
This trial is being conducted at London, Canada, Toronto, Canada.
Who is sponsoring the NCT06725121 clinical trial?
NCT06725121 is sponsored by University Health Network, Toronto. The principal investigator is Gonzalo Sapisochin, MD, PhD, MSc at University Health Network, Toronto. The trial plans to enroll 48 participants.
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