Patients with HCC
Conditions
Interventions
None listed
Sponsors
Hokkaido University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older Patients with Child-Pugh class A Individuals who are 18 years or older at the time of enrollment Patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy Patients with advanced HCC for whom surgical resection, percutaneous local therapy, or transarterial chemoembolization (TACE) is not indicated Individuals scheduled to receive tremelimumab/durvalumab treatment as part of standard medical care Individuals who have received a thorough explanation of the study, fully understand it, and have provided written informed consent of their own free will Individuals with a performance status (PS) of 0 or 1
Exclusion criteria
Exclusion criteria: Individuals with a history of gastrointestinal bleeding from gastric ulcers, esophageal varices, or gastrointestinal varices within the past 12 months. However, for patients at high risk of gastrointestinal bleeding, standard medical care, including pre-treatment upper gastrointestinal examination, is recommended. Individuals with uncontrolled cardiac disease. Individuals with severe hepatic impairment (decompensated liver cirrhosis). Pregnant women, women with a potential for pregnancy, or breastfeeding women. Individuals using medications that are contraindicated according to the package insert. Individuals with a history of prior use of immune checkpoint inhibitors (ICIs), including tremelimumab and durvalumab. Individuals deemed unsuitable for participation in this study by the attending physician. Any other individuals deemed inappropriate as study subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18-month survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Secondary Endpoints Objective response rate (ORR) Overall survival (OS) Progression-free survival (PFS) Disease control rate (DCR) Safety (grade 3 or higher immune-related adverse events (irAEs), irAEs requiring PSL administration) Early response (tumor shrinkage/enlargement rate at the time of the first imaging evaluation) (3) Exploratory Endpoints Efficacy (OS, PFS, ORR, DCR) Safety (grade 3 or higher irAEs, irAEs requiring PSL administration) Association between efficacy (or safety (irAEs)) and gut microbiota as well as its metabolic products | — |
Countries
Japan
Contacts
Public ContactSUDA GOKI
Graduate School of Medicine, Hokkaido University Department of Gastroenterology and Hepatology
Outcome results
None listed