NCT06693128进行中（未招募）2 期
Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Exploratory II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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)
研究组 & 干预措施
Camrelizumab and Apatinib and S-1 and Oxaliplatin
Experimental
干预措施: Camrelizumab (Drug)
Camrelizumab and Apatinib and S-1 and Oxaliplatin
Experimental
干预措施: Apatinib (Drug)
Camrelizumab and Apatinib and S-1 and Oxaliplatin
Experimental
干预措施: S-1, Oxaliplatin (Drug)
Camrelizumab and S-1 and Oxaliplatin
Experimental
干预措施: Camrelizumab (Drug)
Camrelizumab and S-1 and Oxaliplatin
Experimental
干预措施: S-1, Oxaliplatin (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: 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)
次要结局
- Pathologic Nodal Stage after Neoadjuvant Therapy(Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment)
- 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)
- 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)
研究者
研究点 (3)
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