Phase I study of chemotherapy with gemcitabine, CDDP and S-1 for the patients with unresectable biliary tract cancer

Phase I study of chemotherapy with gemcitabine, CDDP and S-1 for the patients with unresectable biliary tract cancer - Chemotherapy for the patients with unresectable biliary tract

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008415

Enrollment

Registered

2012-07-12

Start date

2012-07-01

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

biliary tract cancer

Interventions

dose escalation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patients with inoperable advanced biliary tract cancer including intrahepatic cholangiocarcinoma and ampullary carcinoma diagnosed by pathologically methods or graphically visualizes examination Patients with post-operative recurrent is excluded) 2)Patients of age =>20 and 80> 3)Patientswith Eastern Chemotherapy Oncology Group (ECOG) performance status of 0,1 4)Life expectancy more than 3 months 5)Hemoglobin >=9.0g/dl, WBC>=3,000/mm3,12,000/mm3, neutrophils >=1,500/mm3, platelets >=100,000/mm3, AST/ALT </=100, Total bilirubin </=2.0 x ULN, Serum creatinine </=1.0 x ULN, BUN </=1.0 x ULN, PaO2 >= 70 torr Creatinine clearance>=60 ml/min 6)No other treatments, such as radiation or chemotherapy 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Pulmonary fibrosis or interstitial pneumonia detectable on chest X-ray 2)Active infection 3)Uncontrollable heart disease and myocardial infarction within 6 months 4)Uncontrollable DM 5)Pregnant or lactation women, or women with known or suspected pregnancy 6)History of severe drug allergy 7)Active synchronous or metachronous malignancy

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and determine RD	—

Countries

Japan

Contacts

Public ContactTadashi Uwagawa

Jikei University School of Medicine Department of surgery, Division of hepatobiliary pancreatic surgery

uwagawa@jikei.ac.jp03-3433-1111

Outcome results

None listed

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