NCT04982939Unknown2 期
Efficacy and Safety of Peri-operative Sintilimab in Combination With SOX in Resectable Locally Advanced Gastric Cancer: a Multiple-center Open-label Randomized Phase II Trial.
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年6月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years old ≤ age ≤ 75 years old
- •ECOG PS score 0-1
- •Treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology
- •No known HER2-positive status;
- •Clinical stage Ⅱ, Ⅲ (T1-4a N+ M0, T3-4a N0 M0, AJCC 8th)
- •The research center and the surgeon can complete D2 radical gastrectomy
- •Physical condition and organ function allow for larger abdominal surgery
- •Sufficient organ and bone marrow function, which is defined as follows:
- •Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL.
- •Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ×ULN;
- •Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min (calculated by Cockcroft/Gault formula):
- •Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL))
- •Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL))
- •The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs
- •LVEF≥50%;
- •Agree and be able to comply with the plan during the research period;
- •Provide written informed consent before entering the study screening, and the patient has understood that participants can withdraw from the study at any time during the study without any loss;
排除标准
- •Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome;
- •Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury;
- •Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.;
- •Suffered from other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
- •Uncontrollable pleural effusion, pericardial effusion or ascites;
- •Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction;
- •Allergic reactions to the drugs used in this study;
- •Use steroids or other systemic immunosuppressive therapies 14 days before enrollment;
- •Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials);
- •Active autoimmune diseases;
- •History of primary immunodeficiency;
- •Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10 mg/day Pred nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents;
- •Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study period;
- •Known to have active tuberculosis;
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- •HIV antibody positive, active hepatitis B or C (HBV, HCV);
- •Pregnant or lactating women
研究组 & 干预措施
Experimental Group-Sintilimab in combination with SOX
Experimental
Preoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year.
干预措施: Sintilimab (Drug)
Experimental Group-Sintilimab in combination with SOX
Experimental
Preoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year.
干预措施: S-1 (Drug)
Experimental Group-Sintilimab in combination with SOX
Experimental
Preoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year.
干预措施: Oxaliplatin (Drug)
Active Comparator-SOX
Active Comparator
Preoperative treatment: three cycles of SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX.
干预措施: S-1 (Drug)
Active Comparator-SOX
Active Comparator
Preoperative treatment: three cycles of SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: up to 8 weeks after surgery
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
次要结局
- Tumor down-staging rate(up to 8 weeks after surgery)
- Major pathological response (MPR) rate(up to 8 weeks after surgery)
- 3 years disease-free survival (DFS) rate(up to 4 years)
- Overall response rate ( ORR)(up to 30 days after last preoperative treatment administration)
- 5 years overall survival (OS) rate(up to 6 years)
- Adverse event(up to 30 days after last treatment administration)
- Disease Control Rate (DCR)(up to 30 days after last preoperative treatment administration)
研究者
研究点 (1)
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