Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The prognosis of liver transplanted (LT) patients with recurrence of hepatocellular carcinoma (HCC), especially those with progression after locoregional treatment or advanced HCC, remains poor. Current treatment modalities involve tyrosine kinase inhibitors (TKIs) characterized by a low response rate and often poor tolerability. Encouraging findings from the Imbrave 150 study, demonstrating increased survival rates coupled with favorable treatment tolerance, prompt the investigators to consider the potential of offering the combination of treatment with Atezolizumab-Bevacizumab (Atezo-Beva) to patients with LT. No data regarding the safety and efficacy of this new combination are available for patients with LT as they were not included in Imbrave 150. Immunosuppression after LT is low when compared to essentially all other organ recipients, liver recipients are considered with lower immunological risk. However, the use of ICIs has been associated with a risk of hepatic rejection in LT patients. In this study, in order to prevent acute cellular rejection (ACR) occurrence, we propose to adopt a standardized immunosuppressive regimen closed to the one used immediately after LT but with lower therapeutic goals for tacrolimus and everolimus to allow immunotherapy treatment to be effective. The better tolerance of liver grafts will probably lead to less risk of rejection with Atezo-Beva than in other organ transplants.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-01-22
Completion Date
2030-01-01
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
Systemic therapy
Atezolizumab-Bevacizumab every 3 weeks until progression or side effects in combination with Standardized immunosuppressive treatment: Tacrolimus (objective 5-7 ng/ml) Mycophenolate Mofetil 1000 mg per day Corticosteroids at least 5 mg per day Everolimus will be continued if already started before the inclusion (objective 5-7 ng/ml). If everolimus has not been started prior to inclusion, do not start it, but adopt the following protocol: corticoids + Tacrolimus + Cellcept.
Locations (10)
Hôpital Beaujon
Clichy, France
Hôpital Henri-Mondor
Créteil, France
Hôpital Claude Huriez - CHU de Lille
Lille, France
Lyon - Hôpital Croix Rousse
Lyon, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU Rennes - Hôpital Pontchaillou
Rennes, France
Hôpital de Hautepierre - Strasbourg
Strasbourg, France
CHU Tours - Hôpital Trousseau
Tours, France
Hôpital Paul Brousse
Villejuif, France