Unresectable hepatocellular carcinoma Advanced hepatocellular carcinoma Liver cancer Carcinoma, Hepatocellular Liver Neoplasms Immunotherapy Immune Checkpoint Inhibitors Durvalumab Tremelimumab Portal Vein Thrombosis Expanded Access Programs
Conditions
Interventions
Patients with unresectable hepatocellular carcinoma who received a single priming dose of tremelimumab 300 mg combined with durvalumab 1500 mg on day 1 follow by durvalumab 1500 mg every 4 weeks until
Treatment
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
AstraZeneca Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years or older 2.Diagnosed with unresectable or metastatic hepatocellular carcinoma by radiological or histological criteria 3.Received at least one dose of durvalumab plus tremelimumab under the Expanded Access Program 4.Child-Pugh A or B liver function 5.Any macrovascular invasion status, including portal vein tumor thrombosis, VP1 to VP4 6.Treated at participating tertiary care centres in Thailand between August 2023 and August 2025
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria were based on the Expanded Access Program eligibility requirements. 2.Specific exclusion criteria were not detailed in this retrospective observational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate From first dose to data cutoff Proportion of patients with complete or partial response by RECIST v1.1,Disease Control Rate From fist dose to data cut off Proportion of patients with complete response, partial response, or stable disease by RECIST v1.1,Progression Free Survival From first dose to data cutoff Time from first dose to disease progression or death, Kaplan-Meier method,Overall Survival From first dose to data cutoff Time from first dose to death from any cause, Kaplan-Meier method | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events From first dose to 30 days after last dose Incidence and severity of adverse events graded by CTCAE v5.0,Treatment Discontinuation From first dose to data cutoff Rate of treatment discontinuation due to adverse events,Subgroup Survival From first dose to data cutoff PFS and OS stratified by portal vein thrombosis status and etiology of cirrhosis | — |
Countries
Thailand
Contacts
Public ContactKrittiya Korphaisan
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed