NCT07026149招募中2 期
Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Phase II Trial
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological Complete Response
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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;
- •Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Has adequate organ function.
- •Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- •Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- •Has life expectancy of greater than 12 months.
排除标准
- •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
Arm 1
Experimental
Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
干预措施: Apatinib+Camrelizumab+SOX (Drug)
Arm 1
Experimental
Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
干预措施: Preoperative Radiotherapy (Radiation)
结局指标
主要结局
Pathological Complete Response
时间窗: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
次要结局
- Local control rate(up to 2 years)
- AEs(Up to approximately 18 months)
- Total Pathological Complete Response (tpCR)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Major pathological response(MPR)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Margin-free (R0) resection rate(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Lymph node status after neoadjuvant therapy (ypN staging)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- DFS(up to 2 years)
- OS(up to 2 years)
研究者
研究点 (1)
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