A phase II study of modified FOLFIRINOX(5-FU/LV, irinotecan and oxaliplatin) as second-line chemotherapy for advanced biliary tract cancer after gemcitabine based chemotherapy failure

Gyeongsang National University Hospital0 个研究点目标入组 34 人开始时间: 待定最近更新: 2021年2月23日

试验速览

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•1)Patients with histologically or cytologically confirmed carcinoma (gallbladder, intrahepatic, extrahepatic bili duct origin)
•2)Locally advanced, unresectable or metastatic biliary tract carcinoma not amenable to curative radiotherapy or surgery
•3)Previously treated with gemcitabine-based chemotherapy as palliative 1st-line chemotherapy or relapse after gemcitabine-based adjuvant chemotherapy within 6 months
•4)Age: 19 -75 years
•5)ECOG performance status 0-2
•6)No radiotherapy within 1 month of the study entry
•7)Measurable or evaluable lesion according to RECIST criteria
•8)Adequate marrow, hepatic, renal and cardic function
•-Absolute neutophil count = 1.5 x 109/L; platelets = 100 x 109/L;
•-total bilirubin =1.5xUNL( if due to underlying liver metastasis, then total bilirubin may be =3 xUNL);
•-AST and/or ALT = 3 x UNL; if liver function abnormalities are due to underlying liver metastasis, then AST and/or ALT may be = 5x UNL;
•-Creatinine = 1.5mg/dl or creatinine clearance =50 ml/min
•-Ejection fraction = 50% (on echocardiography within 1 year, or if there is no symptom and age = 60, echocardiography is exempted)
•9)Controlled biliary obstruction more than 2 weeks
•10)Written informed consent must be provided

•1) Locally advanced biliary tract cancer
•2)Prior systemic chemotherapy within 3 weeks
•3)Peripheral neuropathy more than grade 2 before study enrollment
•4)Previously treated with irinotecan and oxaliplatin for the biliary tract cancer
•5)Active CNS metastasis not controllable with radiotherapy or corticosteroid
•-Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases
•-Patients with known, asymptomatic CNS lesions are permitted
•6)Known history of hypersensitivity to study drugs
•7)Past (=5years) or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
•8)Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.
•9)Pregnant or lactating women
•10)Uncontrolled active infection
•11)Prior radiation therapy within 1 month

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