TY  - EJOU
AU  - Korphaisarn, Krittiya 
AU  - Wirasorn, Kosin 
AU  - Tanasanvimon, Suebpong 
AU  - Thanasombunsukh, Kijjakom 
AU  - Maneenil, Kunlatida 
AU  - Thanestada, Jirawat 
AU  - Teeyapun, Nattaya 
AU  - Chindaprasirt, Jarin 
AU  - Sathitruangsak, Chirawadee 
AU  - Siripoon, Teerada 
AU  - Tiraswasdichai, Phannin 
AU  - Charonpongsuntorn, Chanchai 
AU  - Wanchaijiraboon, Passakorn 
AU  - Laosuangkoon, Wannisa 
AU  - Sunpaweravong, Patrapim 
AU  - Sirachainan, Ekapop 
AU  - Akewanlop, Charuwan 

TI  - Efficacy and Safety of Durvalumab plus Tremelimumab for Unresectable Hepatocellular Carcinoma: A Real-World Multicenter Observational Study
T2  - Oncology Research

PY  - 
VL  - 
IS  - 
SN  - 1555-3906

AB  - <b>Introduction:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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). <b>Conclusions:</b> 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.
KW  - Hepatocellular carcinoma; durvalumab; tremelimumab; STRIDE regimen; real-world outcomes; immunotherapy

DO  - 10.32604/or.2026.083206