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ARTICLE

Efficacy and Safety of Durvalumab plus Tremelimumab for Unresectable Hepatocellular Carcinoma: A Real-World Multicenter Observational Study

Krittiya Korphaisarn1,#,*, Kosin Wirasorn2,#, Suebpong Tanasanvimon3, Kijjakom Thanasombunsukh4, Kunlatida Maneenil5, Jirawat Thanestada6, Nattaya Teeyapun3, Jarin Chindaprasirt2, Chirawadee Sathitruangsak7, Teerada Siripoon8, Phannin Tiraswasdichai9, Chanchai Charonpongsuntorn10, Passakorn Wanchaijiraboon11, Wannisa Laosuangkoon12, Patrapim Sunpaweravong7, Ekapop Sirachainan8, Charuwan Akewanlop1
1 Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
2 Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
3 Division of Medical Oncology, Department of Medicine, Faculty of Medicine Chulalongkorn University, Bangkok, Thailand
4 Department of Medicine, Lampang Hospital, Lampang, Thailand
5 Oncology Unit, Rajavithi Hospital, Faculty of Medicine of Rangsit University, Bangkok, Thailand
6 Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand
7 Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
8 Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
9 Sakon Nakhon Hospital, Sakon Nakhon, Thailand
10 Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Srinakharinwirot University, Ongkharak, Nakhon Nayok, Thailand
11 Phrapokklao Cancer Center of Excellence, Phrapokklao Clinical Research Center, Phrapokklao Genomic Laboratories, Phrapokklao Hospital, Mueang District, Chanthaburi, Thailand
12 Udon Thani Hospital, Mueang Udon Thani, Thailand
* Corresponding Author: Krittiya Korphaisarn. Email: email
# These authors contributed equally to this work
(This article belongs to the Special Issue: Advances in Liver Cancer: Novel Therapeutics and Biomarkers for HCC and CCA)

Oncology Research https://doi.org/10.32604/or.2026.083206

Received 01 April 2026; Accepted 03 June 2026; Published online 03 July 2026

Abstract

Introduction: Durvalumab plus tremelimumab (Durva/Treme) improved survival in the HIMALAYA trial for unresectable hepatocellular carcinoma (HCC), but real-world evidence remains limited. This study aimed to evaluate clinical outcomes of Durva/Treme in routine practice. Methods: This retrospective multicenter study included patients with unresectable or advanced HCC who received Durva/Treme through the Expanded Access Program in Thailand between August 2023 and November 2025. Treatment outcomes and adverse events (AEs) were analyzed and descriptively compared with the HIMALAYA trial. Results: Fifty patients were included; median age was 62 years and 80% were male. Etiologies included hepatitis B (44%), hepatitis C (30%), and nonviral liver disease (26%). Most patients had Child–Pugh A (92%), while 24% had macrovascular invasion, including five with Vp4 portal vein involvement. The objective response rate (ORR) and disease control rate (DCR) were 12% and 60%, respectively. Among 43 patients meeting HIMALAYA eligibility criteria, ORR and DCR were 12% and 56%, respectively. With a median follow-up of 28.9 months, median progression-free survival (mPFS) and overall survival (mOS) were 4.6 and 10.5 months in the overall cohort, and 6.9 and 14.0 months in the HIMALAYA-eligible subgroup. Any-grade AEs occurred in 76% of patients, with grade ≥ 3 AEs in 24%. Hepatitis was the most common toxicity (48% overall; 14% grade ≥ 3). Conclusions: Durva/Treme demonstrated clinically meaningful activity with manageable toxicity in unresectable HCC. Outcomes among HIMALAYA-eligible patients were broadly consistent with the pivotal trial, supporting the feasibility of this regimen in routine clinical practice.

Keywords

Hepatocellular carcinoma; durvalumab; tremelimumab; STRIDE regimen; real-world outcomes; immunotherapy

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