Bevacizumab plus Erlotinib maintenance therapy versus observation in advanced biliary tract cancers - a two arm open label prospective integrated Phase II/Phase III parallel design superiority clinical trial.

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1) Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications –
•Biliary tract cancers including gallbladder cancer, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma
•Received palliative gemcitabine based chemotherapy (Gemcitabine- cisplatin /gemcitabine-oxaliplatin /gemcitabine/gemcitabine-capecitabine) for 6 months and having at least stable disease on response evaluation (clinically and radiologically) for at least 2 months prior to inclusion in study.
•2) ECOG performance status 0 - 1
•3) Patient who can give informed consent for the study.
•4) Patient does not have any contraindications to receive chemotherapy, bevacizumab or erlotinib
•5) Adequate hematological, hepatic and renal function parameters•
•7) Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
•8) No major surgery within last 4 weeks
•9) Written patient consent form

•1.Distal cholangiocarcinoma which would be considered as ampullary carcinomas
•2.Known hypersensitivity or contraindications against bevacizumab or erlotinib.
•3.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA II-IV,
•4.Clinically significant valvular defect
•5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
•7.Other severe internal disease or acute infection
•8.Baseline neuropathy more NCI Grade II
•9.Chronic inflammatory bowel disease
•10.Unhealed surgical wounds
•11.Severe hemorrhage
•12.Recent hemoptysis
•13.History of GI perforation
•14.Uncontrolled hypertension
•15.Severe/arterial thromboembolism
•16.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
•17.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment

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