A multicenter single arm phase I study of concurrent radiation and gemcitabine plus cisplatin with durvalumab(MEDI4736) for advanced biliary tract cancer - MARVEL trial

eno Makoto0 个研究点目标入组 36 人开始时间: 2023年10月6日最近更新: 2024年1月22日

试验速览

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•1) Histologically or cytologically proven adenocarcinoma
•2) Unresectable or recurrent biliary tract cancer
•3) No previous chemotherapy or radiotherapy for biliary tract cancer
•4) Aged 20 to 79 years old
•5) Body weight > 30 kg
•6) ECOG performance status of 0 or 1
•7) Presence of lesions with multiple sites
•8) Presence of nonirradiated target lesions.
•9) Presence of metastatic lesions amenable to radiotherapy
•10) Oral intake is possible
•11) Grade1or less of peripheral sensory neuropathy, peripheral motor neuropathy, and tinnitus
•12) Preserved major organ function
•13) Written informed consent

•1) Active double cancer
•2) Receiving any combination of chemotherapy, investigational drugs, and biologic or hormonal therapy for the treatment of cancer
•3) With previous radiotherapy
•4) Active infection
•5) Fever of 38 degrees Celsius or higher
•6) Active autoimmune or inflammatory disease or a confirmed history of such disease
•7) Taking antiplatelet or anticoagulant medication
•8) Complicated by one or more of interstitial pneumonia, pulmonary fibrosis, or severe emphysema
•9) Unhealed fistulas, ulcerative lesions, and active bleeding
•10) Metastases to central nervous system
•11) Moderate or severe ascites and/or pleural effusion
•12) Severe complication
•13) Poorly controlled diabetes
•14) Pregnant or lactating women
•15) Mental disorder
•16) Patients who investigator regards as inappropriate for candidate

发起方

eno Makoto