biliary tract cancer
Conditions
Interventions
The functional food AHCC, which is the test product, will be added to the standard treatment of postoperative adjuvant chemotherapy (S-1 adjuvant therapy)
Sponsors
Komatsu Shohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Individuals aged 18 to 84 years at the time of obtaining consent. 2.Individuals diagnosed with biliary cancer (including intrahepatic bile duct cancer) who have undergone curative surgery for biliary cancer. 3.Individuals scheduled to receive 24 weeks of S-1 therapy within 12 weeks post-surgery as part of adjuvant chemotherapy. 4.Individuals who, after receiving sufficient explanation about the study, have given written informed consent based on their full understanding and voluntary decision to participate.
Exclusion criteria
Exclusion criteria: 1.Individuals with active multiple cancers (synchronous multiple cancers) or those with metachronous multiple cancers with a disease-free interval of 5 years or less. 2.Individuals receiving immunosuppressive doses of corticosteroids (1 mg/day or more). 3.Individuals who are continuously taking supplements related to immune activation. 4.Individuals with psychiatric disorders or psychiatric symptoms that would make participation in the study difficult. 5.Individuals with severe liver dysfunction (AST or ALT > 100 IU/L) or renal dysfunction (creatinine clearance < 50 ml/min). 6.Individuals with severe drug allergies (hypersensitivity). 7.Individuals who have started consuming mushroom (edible) or basidiomycete-derived health foods within one month prior to the registration, or who plan to consume them during the study period (excluding multivitamin supplements). 8.Individuals with allergies to mushroom (edible) or basidiomycete-derived health foods. 9.Individuals with a history of gastric resection or malabsorption syndrome. 10.Pregnant or breastfeeding individuals. 11.Individuals for whom oral intake is difficult. 12.Individuals currently enrolled in other clinical trials or clinical studies. 13.Individuals whom the principal investigator or co-investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The completion rate of S-1 adjuvant chemotherapy (completion is defined as the ratio of the actual total amount of drug administered to the planned dosage being 75% or more, and the completion rate refers to the proportion of subjects who achieved completion). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse event (CTCAE) incidence rate: Collect separately for those caused by AHCC and S-1, starting from Grade 1. - Relative dose intensity of S-1 - Neutrophil count, platelet count - Tumor marker levels (CEA, CA19-9) | — |
Contacts
Public ContactMasayuki Akita
Kobe University Hospital
Outcome results
None listed