Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer
Phase 2
Not yet recruiting
- Conditions
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- Interventions
- Registration Number
- NCT06693128
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+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 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.
- 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
- 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 despite antihypertensive 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Camrelizumab and Apatinib and S-1 and Oxaliplatin Camrelizumab - Camrelizumab and Apatinib and S-1 and Oxaliplatin Apatinib - Camrelizumab and Apatinib and S-1 and Oxaliplatin S-1, Oxaliplatin - Camrelizumab and S-1 and Oxaliplatin Camrelizumab - Camrelizumab and S-1 and Oxaliplatin S-1, Oxaliplatin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Major pathological response (MPR) Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment total Pathologic complete response (tpCR) Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment R0 resection rate Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ypN staging 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 Disease-free survival (DFS) Up to approximately 3 years Overall survival(OS) Up to approximately 5 years AEs Up to approximately 18 months
Trial Locations
- Locations (3)
Sichuan Cancer Hospital & Institute
🇨🇳Chengdu, China
Changhai Hospital
🇨🇳Shanghai, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China