Single-arm phase II study of biweekly nab-Paclitaxel plus Gemcitabine as first-line therapy for elderly patients of unresectable pancreatic cancer

Ikezawa Kenji0 个研究点目标入组 20 人开始时间: 2019年8月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Pathologically-proven adenocarcinoma accompanied by diagnostic imaging consistent with pancreatic cancer
•2) Diagnosed as UR-LA or UR-M by chest/abdominal/pelvic CT
•3) Without uncontrollable pleural effusion or ascites
•4) Age: 75 or more than 75 years old
•5) ECOG Performance status (PS) of 0 or 1
•6) Estimated life expectancy; more than three months
•7) No prior chemotherapy or surgical treatment for pancreatic cancer (except for single laparotomy or digestive tract bypass surgery)
•8) No prior treatment for other organ cancer within 6 months
•9) Adequate function of major organs
•10) Written informed consent

•1) Patients who prefer standard schedule GnP therapy if applicable
•2) Patients who prefer chemoradiation therapy if applicable
•3) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)]
•4) History of unstable angina pectoris or myocardial infarction within 6 months before registration.
•5) Synchronous or metachronous malignancies except for early cancer
•6) Infectious diseases (such as HIV, active tuberculosis, or bacterial infection) requiring systemic treatment, except for viral hepatitis and old pulmonary tuberculosis
•7) Severe psychological disorder
•8) Continuous systemic medication of corticosteroid or immunosuppressant
•9) Pulmonary fibrosis or interstitial pneumonia
•10) The history of adverse reactions to both of iodinated contrast media and gadolinium contrast media
•11) Patients who are judged to be ineligible by investigators

发起方

Ikezawa Kenji