Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer

Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer - Phase II study of S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001614

Enrollment

Registered

2009-01-03

Start date

2007-02-01

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

Gemcitabine-refractory advanced biliary tract cancer

Interventions

S-1 was administered orally for 28 days, followed by 14 days rest (one cycle)until disease progression. Dose of S-1: &lt

1.25m2 80mg/day 1.25m2-1.5m2 100mg/day &gt

1.5m2 120mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent biliary tract cancer 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with gemcitabine-refractory advanced biliary tract cancer 4) Patients with one or more bidimentionally measurable lesions 5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 6) Patients of age >= 20 years 7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. 8) Patients have an ability for a sufficient oral intake 9) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with severe cardiovascular or renal disease 4) Patients with uncontrollable massive pleural effusion or massive ascites 5) Patients with an active concomitant malignancy 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with a previous history of a severe drug hypersensitivity 8) Patients receiving anti-cancer drugs 9) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
Time to progression, Overall survival, Toxicity	—

Countries

Japan

Contacts

Public ContactTakashi Sasaki

Faculty of Medicine, University of Tokyo Department of Gastroenterology

03-3815-5411

Outcome results

None listed

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