Gemicitabine/Cisplatin/nab-paclitaxel for biliary tract cancers (GCA in BTC)
- Conditions
- D001661Biliary tract cancer
- Registration Number
- JPRN-jRCTs051180178
- Lead Sponsor
- Kobayashi Shogo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1) 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
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) <br>Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate
- Secondary Outcome Measures
Name Time Method Histological effect, safety, completion rate, PFS, OS, 1-year and 2-year OS, 1-year and 2-year PFS, site of progression