KCT0000670招募中未知
A phase II study of Irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) histologically confirmation esophageal cancer (adenocarcionma, squamous cell carcinoma)
- •2) disease progresssion proven in baseline scans (CT, MRI) prior two months (Progression according to RECIST version 1.1 criteria should be documented)
- •3) curative surgery, radiation or combination therapy the disease can not be indicated
- •4) the presence of at least one or more measurable target lesion for further evaluation according to RECIST version 1.1
- •5) subjects 20 years of age or older, under 70 years of age.
- •6) ECOG PS 0 or 1
- •7) Subjects treated with chemotherapy, prior to exam registration toxicity resolved to grade 1 or less, and if the last treatment performed at least four weeks prior to the baseline assessment before allowed
- •8) adequate organ function
- •Absolute neutrophil count (ANC) = 1500 / µL
- •- Platelets (Platelets) = 100,000 / µL
- •- Hemoglobin (Hb) = 9.0 g / dL
- •- Serum creatinine = upper limit of normal (ULN) of 1.5 times
- •- Serum bilirubin = 1.5 times the upper limit of normal (ULN) of
- •- AST, ALT = upper limit of normal (ULN) 3.0-fold (liver metastasis, regardless)
- •Commitment to compliance with the study protocol, 9) during the test period and that subjects can adapt
- •10) prior to the test participation and signed a written consent at any time without penalty that you have the right to withdraw your consent from test participation to understand the subject
排除标准
- •1) no measurable lesions
- •2) Sign up for the exam within the previous 4 weeks except for palliative radiation therapy in non-target lesions (conducted within two weeks of the test prior to enrollment) subjects received chemotherapy, radiation therapy, or surgery
- •3) previously received active or passive immunotherapy subjects
- •4), intestinal obstruction, or active upper gastrointestinal bleeding in threatened occlusion, subjects
- •5) pregnant women, or lactating women
- •6) baseline during pregnancy has not been tested or positive results obtained, and subjects of childbearing age. (Duration of amenorrhea 12 months or more after menopause that women of childbearing potential will be considered)
- •7) Men or women of childbearing age will not have to use a method of contraception during the test.
- •8) except cured basal cell skin cancer, and cervical cancer, early gastric cancer, and with a history of other malignant disease within the past five years, subject
- •9) the written consent of or interfere with understanding to affect adherence to drug administration test can be judged clinically significant by researchers believe that uncontrolled seizures, central nervous system disorders, or a history of mental disorders in subjects
- •10) within the past 12 months, clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, myocardial infarction, etc.), or who have experienced subjects
- •11) immunosuppressive therapy that require an organ transplant subjects
- •12) Other researchers improper subjects to judge
研究者
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