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"

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" - Biomarker study for YOTSUBA trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031240320

Enrollment

170

Registered

2024-09-05

Start date

2024-08-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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.).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactTetsuro Sasada

Kanagawa Cancer Center

sasada.0980e@kanagawa-pho.jp+81-45-520-2222

Outcome results