An integrated Phase II/III randomized study comparing durvalumab and tremelimumab ± Hepatic ArteriaL infusion chemotherapy with GEMOX in hepatocellular Carcinoma with high tumor burdEn – ALICE (PRODIGE89 – UCGI44 – ALICE)
Abstract
Patients with advanced hepatocellular carcinoma and high tumour burden (Vp4 PVTT, Vp3 PVTT with bilateral involvement, >50% liver involvement) have poor outcomes and are under-represented in major hepatocellular carcinoma trials (1,2). HAIC has been widely studied in Asian population, with positive results especially in patients with high tumour burden but is not validated in Western population. The ALICE study is a multicentre, French, open-label, randomised integrated phase II/III trial designed to evaluate the safety and efficacy of GEMOX (gemcitabine and oxaliplatin)-based HAIC in combination with durvalumab and tremelimumab, versus durvalumab and tremelimumab alone in this population. A total of 90 and 196 patients will be enrolled in the phase II and phase III components, respectively, and randomised 1:1 between the two treatment arms. Primary endpoints are objective response rate (RECIST 1.1) for phase II and overall survival for phase III. A safety run-in with independent Data and Safety Monitoring Board review is planned during phase II to assess tolerance of the combination. Progression to phase III will depend on a predefined futility rule based on the ORR observed in the experimental arm.
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BibTeX
@article{letissier2026integrated,
title = {{An integrated Phase II/III randomized study comparing durvalumab and tremelimumab ± Hepatic ArteriaL infusion chemotherapy with GEMOX in hepatocellular Carcinoma with high tumor burdEn – ALICE (PRODIGE89 – UCGI44 – ALICE)}},
author = {Octave Letissier and Xavier Adhoute and Boris Campillo-Gimenez and Mohamed Bouattour and Jean-Marie Peron and Amina Larbi and François Ghiringhelli and Yann Touchefeu and Anaïs Vallet-Pichard and Laurent Mineur and Valérie Boige and Antonio Saviano and Jean-Frédéric Blanc and Giuliana Amaddeo and Olivier Rosmorduc and Manon Allaire and Thomas Decaens and Frédéric Di Fiore and Eric Nguyen Khac and Laure Monard and Veronica Pezzella and Aïcha Ben Hariz and Boris Guiu and Julien Edeline},
journal = {Digestive and Liver Disease},
year = {2026},
month = sep,
doi = {10.1016/j.dld.2026.08.030},
url = {https://u-picardie.hal.science/hal-05753461v1},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - An integrated Phase II/III randomized study comparing durvalumab and tremelimumab ± Hepatic ArteriaL infusion chemotherapy with GEMOX in hepatocellular Carcinoma with high tumor burdEn – ALICE (PRODIGE89 – UCGI44 – ALICE)
AU - Octave Letissier
AU - Xavier Adhoute
AU - Boris Campillo-Gimenez
AU - Mohamed Bouattour
AU - Jean-Marie Peron
AU - Amina Larbi
AU - François Ghiringhelli
AU - Yann Touchefeu
AU - Anaïs Vallet-Pichard
AU - Laurent Mineur
AU - Valérie Boige
AU - Antonio Saviano
AU - Jean-Frédéric Blanc
AU - Giuliana Amaddeo
AU - Olivier Rosmorduc
AU - Manon Allaire
AU - Thomas Decaens
AU - Frédéric Di Fiore
AU - Eric Nguyen Khac
AU - Laure Monard
AU - Veronica Pezzella
AU - Aïcha Ben Hariz
AU - Boris Guiu
AU - Julien Edeline
PY - 2026
DA - 2026/09/17
JO - Digestive and Liver Disease
DO - 10.1016/j.dld.2026.08.030
UR - https://u-picardie.hal.science/hal-05753461v1
AB - Patients with advanced hepatocellular carcinoma and high tumour burden (Vp4 PVTT, Vp3 PVTT with bilateral involvement, >50% liver involvement) have poor outcomes and are under-represented in major hepatocellular carcinoma trials (1,2). HAIC has been widely studied in Asian population, with positive results especially in patients with high tumour burden but is not validated in Western population. The ALICE study is a multicentre, French, open-label, randomised integrated phase II/III trial designed to evaluate the safety and efficacy of GEMOX (gemcitabine and oxaliplatin)-based HAIC in combination with durvalumab and tremelimumab, versus durvalumab and tremelimumab alone in this population. A total of 90 and 196 patients will be enrolled in the phase II and phase III components, respectively, and randomised 1:1 between the two treatment arms. Primary endpoints are objective response rate (RECIST 1.1) for phase II and overall survival for phase III. A safety run-in with independent Data and Safety Monitoring Board review is planned during phase II to assess tolerance of the combination. Progression to phase III will depend on a predefined futility rule based on the ORR observed in the experimental arm.
SN - 1590-8658
ER -