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Abstract Details
Ipilimumab with atezolizumab-bevacizumab in patients with advanced hepatocellular carcinoma: The PRODIGE 81-FFCD 2101-TRIPLET-HCC trial
Dig Liver Dis. 2023 Apr;55(4):464-470.doi: 10.1016/j.dld.2023.01.161. Epub 2023 Feb 16.
1Hepatology Unit, University Hospital La Croix-Rousse, INSERM U1052, Centre de Recherche en Cancérologie de Lyon, Lyon, France. Electronic address: philippe.merle@chu-lyon.fr.
2University Hospital of Bordeaux, Digestive Oncology Unit, Bordeaux, France.
3INSERM, Univ Rennes, Department of Medical Oncology, CLCC Eugène Marquis, COSS [(Chemistry Oncogenesis Stress Signaling)] - UMR_S 1242, Rennes, France.
4Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Bourgogne Franche-Comté University, Dijon, France.
5AP-HP Sorbonne Université, Hôpital Universitaire Pitié-Salpêtrière, Service d'Hépato-gastroentérologie, Paris, France.
6Medical Oncology, St-Eloi University Hospital, Montpellier, France.
7AP-HP, Hôpital Universitaire Beaujon, Unité Fonctionnelle Oncologie Hépatique et Innovation Thérapeutique, Clichy France.
8Service d'Hépato-Gastroentérologie, Hôpital Purpan, Toulouse, France.
9INSERM U 775 - Faculté des Sciences Fondamentales et Biomédicales, Center Universitaire des Saints-Pères, Université des Saints Pères, Paris Descartes, Paris, France.
10Hepatology Unit, University Hospital La Croix-Rousse, INSERM U1052, Centre de Recherche en Cancérologie de Lyon, Lyon, France.
11Grenoble Alpes University, Institute for Advanced Biosciences, Research Center UGA/Inserm U 1209/CNRS 5309, Gastroenterology, hepatology and GI oncology department, Digidune, Grenoble Alpes University Hospital, La Tronche, France.
12Department of Radiology, St-Eloi University Hospital, Montpellier, France.
13Sorbonne Université, INSERM, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Saint-Antoine Hospital, Gastroenterology Department, Paris, France; Université Paris-Saclay, INRAE, AgroParisTech, Micalis Institute, Jouy-en-Josas, France; Paris Center for Microbiome Medicine (PaCeMM) FHU, Paris, France.
14Department of Hepato-Gastroenterology, University Hospital of Poitiers, Poitiers, France.
15Service de Gastroentérologie, Hôpital Saint Louis, APHP, Université de Paris, Paris, France.
16AP-HP Paris Nord, Hôpital Universitaire Avicenne, Service d'hépatologie, Paris, France; Centre de Recherche des Cordeliers, Sorbonne Université, Inserm, Université de Paris Cité, team « Functional Genomics of Solid Tumors », Paris, France; Equipe labellisée Ligue Nationale Contre le Cancer, Labex OncoImmunology, France.
17Service d'Hépato-Gastroentérologie et Oncologie Digestive, Hôpital Nord de Saint -Etienne, Saint Priest en Jarez, France.
Abstract
A substantial proportion of patients with hepatocellular carcinoma have to face up, sooner or later, to systemic therapy. The current standards as first line systemic therapies are either atezolizumab (anti-PD-L1) plus bevacizumab (anti-VEGF), or durvalumab (anti-PD-L1) plus tremelimumab (anti-CTLA-4). However, the median overall survival remains below 20 months, and a minority of patients become long-term survivors. Of interest in immune-oncology strategies for hepatocellular carcinoma, the objective response seems to be the most reliable surrogate marker of better overall survival. TRIPLET-HCC (NCT05665348) is a multicentre, randomised, open-label phase II-III trial designed to evaluate efficacy and safety of the triple combination by the addition of ipilimumab (anti-CTLA-4) to atezolizumab/bevacizumab, versus the double atezolizumab/bevacizumab combination. The main inclusion criteria are histologically proven BCLC-B/C HCC without previous systemic therapy. The primary objective of the phase II is the objective response rate in the triple arm, and OS in the triple versus double arms in the phase III. Secondary endpoints common to the phases II and III are the comparisons of progression-free survival, objective response rates, tolerance and quality of life. In addition, genetic and epigenetic studies from tissue and circulating DNA/RNA will be conducted to assess their prognostic or predictive value.