NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1031240320

Registered date:05/09/2024

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"

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedbiliary tract cancer
Date of first enrollment26/08/2024
Target sample size170
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeCreation 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 OutcomeCreation 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 maximumNot applicable
GenderBoth
Include criteriaBiliary 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 criteria1) 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

Contact

Public contact
Name Tetsuro Sasada
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan Kanagawa Japan 241-8515
Telephone +81-45-520-2222
E-mail sasada.0980e@kanagawa-pho.jp
Affiliation Kanagawa Cancer Center
Scientific contact
Name Tetsuro Sasada
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan Kanagawa Japan 241-8515
Telephone +81-45-520-2222
E-mail sasada.0980e@kanagawa-pho.jp
Affiliation Kanagawa Cancer Center