None listed
Conditions
Interventions
Drug : Irinotecan, cisplatin combination chemotherapy
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, time-to-progression, toxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactBhumsuk Keam
Seoul National University Hospital
Outcome results
None listed