Phase I/II study of gemcitabine/cisplatin/nab-paclitaxel for biliary tract cancers with pathological lymph node metastasis (GCA in BTC) - GCA in BTC

Kobayashi Shogo0 个研究点目标入组 20 人开始时间: 2019年3月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

Kobayashi Shogo