hepatobiliary cancer
Conditions
Interventions
Consumption of the test food to the subject, one bottle per day for 24 weeks
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older at the time of consent, who are currently receiving outpatient care at the Department of Hepatobiliary Surgery, Kansai Medical University Hospital 2) Patients diagnosed with hepatocellular carcinoma or cholangiocarcinoma who are scheduled to initiate immune checkpoint inhibitor (ICI) therapy 3) Patients who have received sufficient explanation regarding the study, fully understand its content, and voluntarily provide written informed consent to participate 4) Sex: No restrictions 5) Patients with Performance Status of 0 or 1: PS 0: Fully active, able to carry on all pre-disease performance without restriction PS 1: Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work (e.g., light housework, office work)
Exclusion criteria
Exclusion criteria: 1) Non Japanese individuals 2) Pregnant or breastfeeding individuals 3) Patients with severe comorbidities 4) Patients with psychiatric disorders or symptoms that make study participation difficult, as determined by the investigator 5) Patients with infectious diseases requiring systemic treatment 6) Individuals with difficulty in natural defecation 7) Patients with cows milk allergy 8) Patients with poorly controlled diabetes mellitus 9) Patients with liver cirrhosis classified as Child-Pugh Grade B or Grade C 10) Patients with a history of prior treatment with ICIs 11) Patients receiving continuous corticosteroid therapy or immunosuppressive agents 12) Patients with a history or current diagnosis of autoimmune disease 13) Patients participating in other interventional clinical trials 14) Any individual deemed inappropriate for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival after initiation of pharmacotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events associated with pharmacotherapy Relative dose intensity of pharmacotherapy used at 24 weeks after initiation of ICIs Progression-free survival following initiation of pharmacotherapy Changes in gut microbiota, serum bile acids, cytokines, and Functional Assessment of Cancer Therapy-General (Fact-G), dietary survey | — |
Countries
Japan
Contacts
Public ContactKyoko Inoue
Kansai Medical University Department of Hepatobiliary Surgery
Outcome results
None listed