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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a combination treatment called Atezolizumab-Bevacizumab (Atezo-Beva) for patients who have had a liver transplant and are facing advanced liver cancer known as hepatocellular carcinoma (HCC) that has come back after treatment. The researchers want to see if this new treatment can help these patients live longer and have fewer side effects. Since liver transplant patients have a unique immune system response, the study will also focus on carefully managing their medications to reduce the risk of liver rejection while still allowing the new treatment to work effectively.

To be eligible for the trial, participants must be between 18 and 90 years old, have had a liver transplant more than six months ago, and have advanced liver cancer that cannot be treated with surgery or other local methods. They also need to have at least one measurable cancer lesion that hasn't been treated yet. The trial is not yet recruiting participants, but if someone qualifies, they can expect to receive close medical supervision and support throughout the study to monitor their health and the effects of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * All patients over 18 and under 90 years old:
• • who underwent LT more than 6 months ago (to prevent the higher risk of ACR which exists within the first months after LT and to deal with populations with a lowered immunosuppressive regimen long after LT)
• • with HCC recurrence diagnosis according to the EASL diagnostic criteria (33)
• • with advanced HCC not accessible to surgery and locoregional treatment
• • with at least one measurable untreated lesion
• • With a proposal for Atezo-Beva in first line treatment made in a multidisciplinary meeting
• • ECOG Performance Status of 0 or 1
• • For women of childbearing potential and men: agreement to remain abstinent
• • Child-Pugh class A
• Exclusion Criteria:
• • History of ACR within 3 months before starting Atezo-Beva treatment
• • Banff score for acute cellular rejection ≥ 3 on liver biopsy performed before the initiation of the treatment
• • Pregnant or breastfeeding woman
• • Patient not affiliated to a beneficiary or entitled social security scheme or to the PUMA
• • Patient not having signed consent
• • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT-scan
• • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
• • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
• • Inadequately controlled arterial hypertension
• • Prior history of hypertensive crisis or hypertensive encephalopathy
• • History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
• • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses