Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.
详细描述
The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
- •Willing to sign ICF
- •Above 18 years
- •KPS score≥70
- •Expected survival time more than 90 days
- •Subjects with EGFR overexpression (2+ or 3+ in IHC)
- •With target lesions in spiral CT or MRI examination within 30 days
- •Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
- •Lab test of baseline meet following criteria
- •Hemoglobin higher than 9.0g/dL
- •Neutrophil higher than 1,500/mm3
- •PLT higher than 10.0 104/mm3
- •Bilirubin lower than 1.5 times of upper limit of normal range
- •AST,ALT,ALP lower than 2.5 times of upper limit of normal range
- •Creatinine lower than upper limit of normal range
- •When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
排除标准
- •Patients who have received irinotecan
- •Patients who are allergic to irinotecan or nimotuzumab.
- •Other active malignancy within the last 5 years
- •Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
- •Investigator judge not eligible to this trial
研究组 & 干预措施
irinotecan and nimotuzumab
Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
干预措施: Irinotecan (Drug)
irinotecan and nimotuzumab
Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
干预措施: nimotuzumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response
次要结局
- Disease control rate(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Overall survival(3 years after first enrollment)
- Progression free survival(3 years after first enrollment)
- Safety(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Potential predictive biomarkers of nimotuzumab(3 years after first enrollment)
研究者
Shen Lin
Head of Department of GI oncology, Beijing Cancer Hospital
Peking University