NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180178

Registered date:26/03/2019

Gemicitabine/Cisplatin/nab-paclitaxel for biliary tract cancers (GCA in BTC)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBiliary tract cancer
Date of first enrollment12/02/2018
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)gemcitabine 600, 800, 1000 mg/m2 cisplatin 25 mg/m2 nab-PTX 80, 100, 125 mg/m2 day 1 and8, every 3 weeks 2 cycles.

Outcome(s)

Primary OutcomePhase I: Feasibilty (MTD and RD) Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate
Secondary OutcomeHistological effect, safety, completion rate, PFS, OS, 1-year and 2-year OS, 1-year and 2-year PFS, site of progression

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) age> 20. 2) PS 0-1 3) no impairment of bone marrow, liver, renal, cardiac, and pulmonary function: 3-a) neutrophil >= 2000/mm3 3-b) platelet >= 100,000/mm3 3-c) hemoglobin >= 9.0 g/dL 3-d) bilirubin <= 2.0 mg/dL 3-e) AST, ALT <= 5 x UNL 3-f) creatinine <= 1.5 mg/dL 4) written informed consent
Exclude criteria1) distant metastasis 2) estimated remnant liver volume after PTPE would become under 35% because the measurement includes resectability 3) active cancers, without carcinoma in situ 4) suspected or definitive pulmonary fibrosis or interstitial pneumonia 5) watery diarrhea 6) active infection without viral hepatitis nor cholangitis 7) severe complications: cardiac, renal, liver failure, bleeding peptic ulcer, bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus 8) pregnancy 9) severe mental disorder 10) severe allergy 11) entry on other studies 12) inappropriate by the investigators

Related Information

Contact

Public contact
Name Shogo Kobayashi
Address 2-15, Yamadaoka, Suita, Osaka 565-0871, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail s-kobayashi@umin.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Shogo Kobayashi
Address 2-15, Yamadaoka, SUita, Osaka 565-0871, JAPAN Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail s-kobayashi@umin.ac.jp
Affiliation Osaka University Hospital