Cisplatin and S-1 With or Without Nimotuzumab for Patients With Previously Untreated Advanced Gastric Adenocarcinoma: a Single-center, Randomised, Open-label, Parallel-group, Controlled Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
研究概览
简要总结
In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group.
The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.
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
- •provision of written informed consent;
- •male or female; and aged ≥ 18 years;
- •Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction;
- •At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria;
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy ≥ 3months;
- •No previous palliative chemotherapy;
- •Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils (ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL, normal electrocardiography (ECG).
排除标准
- •pregnant or lactating patients, or reproductive women without effective contraception;
- •Patients with only non-measurable disease: small lesions (longest diameter < 10mm or pathological lymph nodes with ≥ 10 to < 15mm short axis), Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques.
- •Symptomatic of brain metastasis;
- •Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits );
- •No previous radiotherapy for measurable lesions.
研究组 & 干预措施
NCS
nimotuzumab plus cisplatin and S-1
干预措施: nimotuzumab (Drug)
NCS
nimotuzumab plus cisplatin and S-1
干预措施: cisplatin (Drug)
NCS
nimotuzumab plus cisplatin and S-1
干预措施: S-1 (Drug)
CS
cisplatin and S-1
干预措施: cisplatin (Drug)
CS
cisplatin and S-1
干预措施: S-1 (Drug)
结局指标
主要结局
Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
时间窗: 5 years
次要结局
- Progression-free survival measured by RECIST 1.1(5 years)
- Time to progression as measured by RECIST 1.1(5 years)
- Treatment safety and toxicity as measured by Common Toxicity Criteria for Adverse Effects(CTCAE 3.0)(5 years)
研究者
yihebali chi
Assistant Professor
Chinese Academy of Medical Sciences