Biliary tract cancer
Conditions
Interventions
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.
Sponsors
Osaka Univiersity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) PS 0-1 2) no impairment of bone marrow, liver, renal, cardiac, and pulmonary function: 2-a) neutrophil >= 2000/mm3 2-b) platelet >= 100,000/mm3 2-c) hemoglobin >= 9.0 g/dL 2-d) bilirubin <= 2.0 mg/dL 2-e) AST, ALT <= 5 x UNL 2-f) creatinine <= 1.5 mg/dL 3) written informed consent
Exclusion criteria
Exclusion criteria: 1) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Feasibilty (MTD and RD) Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate | — |
Countries
Japan
Contacts
Public ContactShogo Kobayashi
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed