Actively Recruiting
Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-10
50
Participants Needed
10
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years
- Liver transplant performed more than 6 months ago
- Diagnosis of recurrent hepatocellular carcinoma (HCC) according to EASL criteria
- Advanced HCC not suitable for surgery or locoregional treatment
- At least one measurable untreated tumor lesion
- Planned first-line treatment with Atezolizumab-Bevacizumab decided by a multidisciplinary team
- Adequate blood counts and organ function within 14 days before treatment
- ECOG Performance Status of 0 or 1
- Agreement to use effective contraception or abstinence during treatment and specified months after treatment if applicable
- Child-Pugh liver function class A
You will not qualify if you...
- Acute cellular rejection within 3 months before starting treatment
- Banff score for acute cellular rejection of 3 or higher on liver biopsy before treatment
- Pregnant or breastfeeding women
- Not affiliated with a social security or beneficiary scheme
- No signed informed consent
- History of certain lung diseases or active pneumonitis
- History of malignancies other than HCC within 5 years except low-risk cancers
- Untreated or high-risk esophageal or gastric varices
- Bleeding from varices within 6 months before treatment
- Uncontrolled high blood pressure or history of hypertensive crisis
- Intestinal obstruction or symptoms requiring parenteral hydration
- Serious wounds, active ulcers, or untreated bone fractures
- Metastatic disease involving major airways, blood vessels, or central mediastinal tumors
- Allergy to study drugs or related products
- History of arterial thromboembolic events
- Significant recent cardiovascular disease or unstable heart conditions
- Proteinuria greater than 1 gram in 24 hours
- History of leptomeningeal disease
- Active tuberculosis
- Severe infection within 4 weeks before treatment start
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Hôpital Beaujon
Clichy, France, 92110
Actively Recruiting
2
Hôpital Henri-Mondor
Créteil, France, 94010
Actively Recruiting
3
Hôpital Claude Huriez - CHU de Lille
Lille, France, 59037
Actively Recruiting
4
Lyon - Hôpital Croix Rousse
Lyon, France, 69004
Actively Recruiting
5
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
6
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
7
CHU Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
8
Hôpital de Hautepierre - Strasbourg
Strasbourg, France, 67200
Actively Recruiting
9
CHU Tours - Hôpital Trousseau
Tours, France, 37044
Actively Recruiting
10
Hôpital Paul Brousse
Villejuif, France, 94800
Actively Recruiting
Research Team
M
Manon Allaire, MD
CONTACT
A
Anne Bissery
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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