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Review
. 2025 Jun:137:102955.
doi: 10.1016/j.ctrv.2025.102955. Epub 2025 May 9.

The present and the future of immunotherapy in hepatocellular carcinoma and biliary tract cancers

Giuseppe Cabibbo  1 , Lorenza Rimassa  2 , Angela Lamarca  3 , Gianluca Masi  4 , Bruno Daniele  5 , David James Pinato  6 , Andrea Casadei-Gardini  7
Affiliations
Free article
Review

The present and the future of immunotherapy in hepatocellular carcinoma and biliary tract cancers

Giuseppe Cabibbo et al. Cancer Treat Rev. 2025 Jun.
Free article

Abstract

Hepatobiliary malignancies encompass a spectrum of invasive carcinomas arising in the liver [hepatocellular carcinoma (HCC), bile ducts [intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (EHC)] and the gallbladder. These malignancies represent a growing global health burden, with rising incidence and mortality rates and their overall prognosis remains poor because many patients present with advanced unresectable disease at diagnosis. In recent years, significant advancements in understanding HCC immunogenicity have reshaped the therapeutic scenario of advanced HCC with the immunotherapy revolutionizing the current HCC treatment landscape and patients' prognosis. Moreover, the addition of immunotherapy to chemotherapy has recently established a new standard of care first-line treatment for patients with biliary tract cancers (BTCs) who had historically few therapeutic options. Currently, immunotherapy and immune checkpoint inhibitor (ICI)-based regimens stand as a valuable and practice-changing options in both HCC and BTC management. The mounting recent evidence supporting immunotherapy's survival benefit demands clinicians to stay updated with a rapidly evolving treatment landscape as well as gain knowledge about patient selection, response rate compared with other systemic treatments and immune-mediated adverse events (imAEs) management. A panel of international Experts, comprising hepatologists and oncologists, gathered to explore the challenges in effectively integrating immunotherapy in routine clinical practice. The aim of this review is to present the Experts' insights to inform treatment choice in HCC and BTC with a special emphasis on the role of currently available ICI-based therapies in shifting treatment paradigms and potentially reversing the natural course of these two deadly malignancies.

Keywords: Biliary tract cancer; Combination therapy; Hepatocellular carcinoma; Immune-checkpoint inhibitor; Immunotherapy; Systemic therapy.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: GC participated in advisory board and received speaker fees from Bayer, Eisai, Ipsen, and AstraZeneca, MSD, Roche, Gilead. LR reports grant/research funding (to institution) from AbbVie, AstraZeneca, BeiGene, Exelixis, Fibrogen, Incyte, IPSEN, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, TransThera Sciences, and Zymeworks; consulting fees from AbbVie, AstraZeneca, Basilea, Bayer, Bristol Myers Squibb, Eisai, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, IPSEN, Jazz Pharmaceuticals, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, and Zymeworks; lecture fees from AstraZeneca, Bayer, Bristol Myers Squibb, Guerbet, Incyte, IPSEN, Roche, and Servier; and travel expenses from AstraZeneca and Servier. AL declares travel and educational support from Ipsen, Pfizer, Bayer, AAA, SirtEx, Novartis, Mylan, Delcath Advanz Pharma and Roche; speaker honoraria from Merck, Pfizer, Ipsen, Incyte, AAA/Novartis, QED, Servier, Astra Zeneca, EISAI, Roche, Advanz Pharma and MSD; advisory and consultancy honoraria from EISAI, Nutricia, Ipsen, QED, Roche, Servier, Boston Scientific, Albireo Pharma, AstraZeneca, Boehringer Ingelheim, GENFIT, TransThera Biosciences, Taiho and MSD; principal Investigator-associated Institutional Funding form QED, Merck, Boehringer Ingelheim, Servier, Astra Zeneca, GenFit, Panbela Therapeutics, Novocure GmbH, Camurus AB, Albireo Pharma, Taiho, TransThera, Jazz Therapeutics and Roche; member of the Knowledge Network and NETConnect Initiatives funded by Ipsen. DJP reports lecture fees from Bayer Healthcare, BMS, Roche, Eisai, Falk Foundation, Incyte, Boston Scientific, travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, Elevar Therapeutics, EISAI, Roche, DaVolterra, Mursla, Starpharma, Exact Sciences and Astra Zeneca; research funding (paid to institution) from MSD, GSK and BMS. ACG reports consulting fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, IQVIA, MSD, Roche, Servier ; lecture fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Servier; travel expenses from AstraZeneca; research grants (to Institution) from AstraZeneca, Eisai. BD reports advisory and consultancy honoraria from Roche, AstraZeneca, Incyte, MSD, EISAI, Novocure, Servier, BMS and travel expenses from Roche and AstraZeneca. GM reports advisory honoraria from AstraZeneca, Bayer, Ipsen, MSD, EISAI, Roche, Sirtex; speaking honoraria from Amgen, AstraZeneca, Roche, MSD, EISAI, Terumo, Sirtex and travel expenses from AstraZeneca, Bayer, Ipsen, MSD, EISAI, Roche. GM also repors research funding (paid to institution) by Roche, Terumo, Sirtex.

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