Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
Capecitabine
Oxaliplatin
Apatinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has histologically- or cytologically-confirmed diagnosis of locally advancedunresectable or mestastatic adenocarcinoma of stomach or the esophagogastricjunction (GEJ)
Age ≥ 18 years old, male or female
NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER-2inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
Has measurable disease per RECIST 1.1
Eastern Cooperative Group (ECOG) performance status of 0 to 1
Has adequate organ function
Females of childbearing potential (FOCBP), who are not surgically sterile orpostmenopausal, must conduct pregnancy test (serum or urine) within 7 days beforeenrollment, and must not be pregnant or breast-feeding women. If the result isnegative, she must agree to use adequate contraception during the experiment and 3months after the last administration of the test drugs. And non-sterilized males whoare sexually active must agree to use adequate contraception during the experimentand 3 months after the last administration of the test drugs.
Exclusion
Exclusion Criteria:
Has known HER2-positive status
Has known active central nervous system metastatases
Has received a live vaccine within 4 weeks prior to the first dose of studytreatment
With any acitve autoimmune disease or history of autoimmune disease, including butnot limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism,and hypothyroidism, except for subjects with vitiligo or resolved childhoodasthma/atopy. Asthma that requires intermittent use of bronchodilators or othermedical intervention should also be excluded.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody,or a VEGFR inhibitor.
Clinically significant cardiovascular and cerebrovascular diseases, including butnot limited to severe acute myocardial infarction within 6 months before enrollment,unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.
Hypertension and unable to be controlled within normal level following treatment ofanti-hypertension agents: systolic blood pressure > 140 mmHg, diastolic bloodpressure > 90 mmHg.
Study Design
Connect with a study center
Beijing Cancer Hospital, Peking University
Beijing, Beijing
ChinaSite Not Available
Beijing Cancer Hospital, Peking University
Beijing 1816670, Beijing Municipality 2038349
ChinaSite Not Available

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