Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Health Network, Toronto
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18-70
Weight > 30 kg
Child Pugh Turcotte score A5 to B7
Macrovascular invasion (Vp1-3)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab & Bevacizumab
Biological/VaccineAtezolizumab \& 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.
Yttrium-90 (Y-90)
DrugStorage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.
Stereotactic body radiotherapy (SBRT)
RadiationDose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: TreatmentOther 3 interventions
Trial outcomes
Primary outcomes
1
Evaluate Downstaging Efficacy
The number of patients who achieve a liver transplant.
Time frame
From enrollment to liver transplantation.Secondary outcomes
1
Long-term Oncological Results
The objective is to determine the 5-year overall survival (OS) and recurrence free survival (RFS) in the proportion having received a liver transplant.
Time frame
Form enrollment to 5 years post-transplant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov