Phase
Condition
Adenocarcinoma
Treatment
Camrelizumab
Apatinib
S-1, Oxaliplatin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has previously untreated localized gastric or GEJ adenocarcinoma as defined byT3-4N+M0 (according to AJCC 8th edition) ;
Plans to proceed to surgery after completion of neoadjuvant therapy;
Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Has adequate organ function.
Female subjects of childbearing potential must have a negative serum pregnancy testwithin 72 hours prior to the first dose, and be willing to use a highly effectivemethod of contraception during the study and for 2 months after the last dose ofcarrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs,whichever is longer.
Male subjects whose partners are women of reproductive age should be surgicallysterilized or agree to use highly effective methods of contraception during thestudy and for 2 months after the last administration of carrilizumab or 8 weeksafter apatinib or 3 months after chemotherapy drugs, whichever is longer. Spermdonation is not allowed during the study.
Exclusion
Exclusion Criteria:
Known HER2 positive;
Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
Previous or concurrent malignancies, except for cured basal cell carcinoma of skin,carcinoma in situ of cervix, and carcinoma in situ of breast;
Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despiteantihypertensive therapy);
Known hypersensitivity to any of the study drugs or excipients;
Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs,coagulation disorders, thrombocytopenia, etc.);
Congenital or acquired immune deficiency (e.g. HIV infected)
Study Design
Connect with a study center
Sichuan Cancer Hospital & Institute
Chengdu,
ChinaSite Not Available
Sichuan Cancer Hospital & Institute
Chengdu 1815286,
ChinaSite Not Available
Changhai Hospital
Shanghai,
ChinaSite Not Available
Changhai Hospital
Shanghai 1796236,
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai,
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai 1787093,
ChinaSite Not Available

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