Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Downstaging | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Transplant Surgery | — | UNRESOLVED | — |
| Macrovascular Invasion | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab & Bevacizumab | Biological | — | UNRESOLVED |
| Stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
| Yttrium-90 (Y-90) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- This is a pilot, single-arm study enrolling 48 patients to evaluate the feasibility of locoregional therapy followed by immunotherapy in patients with advanced liver cancer. Patients will receive stereotactic body radiotherapy or Yttrium-90 radioembolization as per the standard-of-care (SOC) protocol, determined during Multidisciplinary Rounds. Starting two to six weeks after radiotherapy, patients will begin treatment with Atezolizumab and Bevacizumab administered in approximately 21-day intervals, following SOC procedures, for a maximum of 9 months. Clinical follow-up will align with SOC protocols, and imaging will be performed every 2-3 months during immunotherapy. If a patient is sufficiently responding to treatment at any follow-up, patients will be referred for transplant evaluation and added to the waitlist if no contraindications are found. Patients with disease progression or who become ineligible for LT due to other factors will be transitioned off the study.
- interventionNames
- Biological: Atezolizumab & Bevacizumab
- Drug: Yttrium-90 (Y-90)
- Radiation: Stereotactic body radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Evaluate Downstaging Efficacy
- timeFrame
- From enrollment to liver transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available