Exploratory study of biomarkers associated with "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer"

JRCT ID: jRCT1031240320

Registered date:05/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: biliary tract cancer
• Date of first enrollment: 26/08/2024
• Target sample size: 170
• Study type: Observational

Outcome(s)

• Primary Outcome: Creation of a multivariate discriminant model by combination of plasma amino acid concentrations to predict overall survival in advanced biliary tract cancer patients treated with gemcitabine/cisplatin/S-1 combination therapy and gemcitabine/cisplatin/immune checkpoint inhibitor combination therapy.
• Secondary Outcome: Creation of a multivariate discriminant model by combination of plasma amino acid concentrations to predict progression-free survival in advanced biliary tract cancer patients treated with gemcitabine/cisplatin/S-1 combination therapy and gemcitabine/cisplatin/immune checkpoint inhibitor combination therapy.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Biliary tract cancer patients enrolled in "Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer" (KHBO-2201)

Exclude criteria

1) History of immunotherapy (anti-PD-1/PD-L1 antibody therapy, anti-CTLA-4 antibody therapy, cancer vaccine therapy, immune cell therapy, etc.).
2) Regular use of amino acid preparations (intravenous nutrition, enteral component nutrition, etc.) or amino acid supplements (concomitant use of anamorelin hydrochloride is acceptable).
3) Presumed abnormalities of amino acid metabolism (cirrhosis, renal failure, congenital abnormalities of amino acid metabolism, etc.).

Related Information

• Primary Sponsor: Sasada Tetsuro