Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Conditions
Brief summary
This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Interventions
DRUGCamrelizumab
Camrelizumab 200mg
DRUGApatinib
Apatinib 250mg
DRUGS-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0 (according to AJCC 8th edition) ; 2. Plans to proceed to surgery after completion of neoadjuvant therapy; 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 4. Has adequate organ function. 5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer. 6. Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.
Exclusion criteria
1. Known HER2 positive; 2. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 3. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 4. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 5. Known hypersensitivity to any of the study drugs or excipients; 6. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 7. Congenital or acquired immune deficiency (e.g. HIV infected)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a) |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS) | Up to approximately 5 years |
| AEs | Up to approximately 18 months |
| Major pathological response (MPR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Disease-free survival (DFS) | Up to approximately 3 years |
| R0 resection rate | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Pathologic Nodal Stage after Neoadjuvant Therapy | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Event free survival (EFS) | Up to approximately 3 years |
| total Pathologic complete response (tpCR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhenggang Zhu
Ruijin Hospital
PRINCIPAL_INVESTIGATORYantao Tian
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed