Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.

Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites. - Feasibility study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced biliary tract cancer with carcinomatous ascites.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007520

Enrollment

Registered

2012-03-21

Start date

2012-04-01

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

Advanced biliary tract cancer with carcinomatous ascites

Interventions

S-1 40mg/m2 is administered orally twice a day from day 1 to day 14 followed by a one-week rest.Paclitaxel 50mg/m2 is administered intravenously and paclitaxel 20mg/m2 is administered intraperitoneall

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with pathologically confirmed biliary tract cancer 2) Patients with cytologically confirmed cacinomatous ascites 3) Patients of age >= 20 years 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) 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. no abnormal clinical findings in ECG. 6) Patients have an ability for a sufficient oral intake 7) Patients refractory to gemcitabine 8) Patients recovery from prior adverse events 9) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1) Patients with synchronous or metachronous concomitant malignancies 2) Patients with uncontrolled diabetes mellitus 3) Patients with uncontrolled hypertension 4) Patients with renal failure undergoing hemodialysis 5) Patients with prior myocardial infarction or unstable angina within 6 months 6) Patients with liver cirrhosis 7) Patients with intestinal pneumonia, pulmonary fibrosis, and severe pulmonary emphysema 8) Pregnant or lactating female and patients who is considering pregnancy 9) Patients with contraindication for S-1 or paclitaxel 10) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression-free survival Anti-tumor effect(Response rate, Disease control rate) Effect for carcinomatous ascites One-year survival rate Drug administration compliance(Drug intensity, Drug feasibility)	—

Countries

Japan

Contacts

Public ContactNaminatsu Takahara

The University of Tokyo Gastroenterology

takaharan-int@h.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

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