Phase I / II Study of GEM/Cisplatin/nab-PTX for Biliary tract cancer with pathological lymph node metastasis
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000029490
- Lead Sponsor
- Osaka Univiersity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Feasibilty (MTD and RD) Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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