RecruitingPhase 2NCT06254248

Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

50 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug combination called atezolizumab plus bevacizumab (Atezo-Beva) is safe and effective in liver transplant patients who have liver cancer (hepatocellular carcinoma) that has come back after their transplant. Immunotherapy drugs are typically avoided in transplant patients due to rejection risks, so this trial carefully explores whether they can be used safely. **You may be eligible if...** - You are aged 18–90 and received a liver transplant at least 6 months ago - Your liver cancer has returned and cannot be removed by surgery or treated with local procedures - You have at least one measurable, untreated tumor - Your doctors have recommended Atezo-Beva as first-line treatment - Your organ function meets the required laboratory thresholds **You may NOT be eligible if...** - Your liver transplant was less than 6 months ago - You have received other systemic cancer therapies before this - You have active autoimmune disease requiring systemic immunosuppression - Your organ function is too poor for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystemic 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

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NCT06254248


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