NCT05975749招募中2 期
A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection
适应症
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
- 114
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
- •Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
- •R0 gastrectomy with D2 lymphadenectomy
- •Her2+ diagnosed by Immunohistochemistry or FISH
- •ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- •No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).
排除标准
- •Patients with stage I and IV.
- •Unavailable for R0 resection and D2 lymph node dissection.
- •Multiple primary tumors
- •Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- •History of chemotherapy, radiotherapy, immunotherapy or target therapy.
研究组 & 干预措施
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Experimental
干预措施: Serplulimab (Drug)
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Experimental
干预措施: Trastuzuma (Drug)
Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy
Experimental
干预措施: Chemotherapy (Drug)
Adjuvant Chemotherapy only
Active Comparator
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3-year
DFS
次要结局
- Side effects(12 months])
- Overall survival(3-year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction AdenocarcinomaMalignant Neoplasm of StomachMalignant Neoplasm of Cardio-esophageal Junction of StomachEpidermal Growth Factor Receptor (EGFR) Protein OverexpressionNCT02205047European Organisation for Research and Treatment of Cancer - EORTC172
终止
2 期
Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric CancerGastroesophageal Junction CancerGastric CancerNCT02726399Memorial Sloan Kettering Cancer Center7
已完成
2 期
Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune CytopeniasAnemia, Hemolytic, AutoimmuneIdiopathic Thrombocytopenic PurpuraNCT00749112Hospital Universitario Dr. Jose E. Gonzalez19
Unknown
2 期
Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast CancerHER-2 Positive Breast CancerNCT01428414Zhimin Shao100
招募中
2 期
Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma PatientsEsophageal Squamous Cell CarcinomaHER-2 Protein OverexpressionHER-2 Gene AmplificationNCT05170256Morten Mau-Sørensen24