Phase
Condition
Carcinoma
Adenocarcinoma
Gastric Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
sign written informed consent form
age ≥ 18 years
pathologically confirmed gastric or GEJ adenocarcinoma
disease at clinical stage of resectable or potentially resectable LAGC(T4a-b/N+M0)
No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immunetherapy or target therapy
Adequate organ function as defined below: Hematologic ANC ≥ 1.5109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN RenalSerum Creatinine < 1.5 ULN
KPS ≥ 70
Adequate lung and heart function
Negative serum or urine pregnant test within 7 days prior to randomization forchild-bearing age women
Sexually active males or females willing to practice contraception during the studyuntil 30 days after end of study.
Exclusion
Exclusion Criteria:
Refuse to provide blood/tissue sample;
With distant metastasis;
Sexually active males or females refuse to practice contraception during the studyuntil 30 days after end of study.
Known hypersensitivity reaction or metabolic disorder to fluorpyrimidines oroxaliplatin;
≥ grade 1 peripheral neuropathy;
History of organ transplantation(including autologous bone marrow transplantation andPeripheral stem cell transplantation);
Prior long term steroid therapy (excluding short term steroid treatment which iscompleted prior to > 2 weeks of study enrollment);
Patients with central nervous system(CNS) disorder or peripheral nervous systemdisorder or psychiatric disease;
Concurrent severe infection;
unable to swallow; (complete or incomplete)gastrointestinal obstruction;gastrointestinal bleeding; gastrointestinal perforation;
Concurrent disease or condition that would make the subject inappropriate for studyparticipation or any serious medical disorder that would interfere with the subject'ssafety (including current active hepatic, biliary, renal, respiratory disease,uncontrolled diabetes hypertension et al);
History of other malignancy. However, subjects who have been disease-free for 5 years,or subjects with a history of completely resected non-melanoma skin cancer orsuccessfully treated in situ carcinoma, are eligible;
Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias andhypertension, or congestive heart failure, or cardiac infarction within 6 months priorto study enrollment, or cardiac insufficiency;
Person with no capacity (legally) or inappropriate to continue study treatment forethics/medical reasons;
Study Design
Study Description
Connect with a study center
Lin Shen
Beijing,
ChinaSite Not Available
Peking Unicersity Cancer Hospital
Beijing,
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.