Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer - Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009536

Enrollment

Registered

2012-12-13

Start date

2011-08-30

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

Gemcitabine: day1, 15 Cisplatin: day1, 15 S-1: day1-7, day15-21

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven biliary tract cancer. 2)Recurrent or unresectable Advanced Biliary Tract Cancer. 3)No prior chemothearpy or radiotherapy for Biliary Tract Cancer. 4)Aged 20 to 79 years old. 5)ECOG performance status of 0 or 1. 6)Adequate organ function. 7)Oral intake is possible. 8)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Simultaneous or metachronous double cancers. 2)Severe complications. 3)The case suspected of infection with feaver. 4)A history of motor paralysis or peripheral neuropathy or edema. 5)Pleural or cardiac effusion requiring treatment. 6)Massive abdominal effusion. 7)Pregnancy or the desire to preserve fecundity. 8)Active lung disease such as interstitial pneumonia or pulmonary fibrosis. 9)Mental disease or psychotic manifestation. 10) A history of serious drug allergy. 11)A history of sever allergic reaction with gemcitabine or cisplatin or S-1. 12)Being treated with other pyrimidine fluoride antineoplastic agents. 13)Being treated with flucytosine. 14)Any patients judged by the investigator to be unfit to participate in the study.

Design outcomes

Primary

Measure	Time frame
To determinate MTD and RD.	—

Secondary

Measure	Time frame
Safety	—

Countries

Japan

Contacts

Public ContactMitsuhiro Kida

Kitasato University School of Medicine Department of Gastroenterology

042-748-9111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026