phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer - phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer

Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine0 个研究点目标入组 36 人开始时间: 2012年3月23日最近更新: 2023年10月17日

适应症

试验速览

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•1 biliary tract cancer confirmed adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer) 2 in operable advanced biliary tract cancer (include locally advanced or recurence) The presence or absence of measurable lesion does not matter. The patient with the measurable lesion conducting an examination for image within 28 days before registration. 3 with no prior therapy except for resection Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day. 4 age 20 to 80 at registration 5 PS 0-1 6 sufficient function of important organs WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 Hem:>=10.0g/dl GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present) GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) serum Cr: =< 1.2mg/dL Ccr:>=60 ml/min/body 7 oral intake 8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration 9 written informed consent 10 with interstitial pneumonia and lungs fiber syndrome

发起方

Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine