Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab
研究概览
简要总结
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
详细描述
An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent
- •male or female patient at an age of 18 years or older
- •patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- •TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
- •indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
- •intended curative gastrectomy
- •Karnofsky index > 70
排除标准
- •Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
- •prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
- •previous use of non-humanized monoclonal mouse or rat antibodies
- •treatment with another investigational product during this study or during the last 30 days prior to study start
- •presence of distant metastases
- •presence of constant immunosuppressive therapy
- •history of pancreas resection (also partial) or thoracotomy
- •presence of any acute or chronic systemic infection
- •patient with a bowel obstruction within the last 30 days
- •known contraindications to any of the planned ECX chemotherapeutics
研究组 & 干预措施
catumaxomab arm
Patients will get first the chemotherapeutic regimen (Epirubicin, Cisplatin and Capecitabine or 5-Fluorouracil) consisting of three 21-day cycles, starting on the weeks 1, 4 and 7. Four weeks after CTx the D2 surgery will take place. Treatment with catumaxomab will consist of an initial dose of 10µg given intraoperatively as in intraperitoneal bolus and of four postoperative ascending doses.
干预措施: catumaxomab (Drug)
结局指标
主要结局
rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab
时间窗: 30 days after last catumaxomab administration
次要结局
- frequency, relationship and seriousness of adverse events(30 days after last catumaxomab administration)
- surgical resection rate(after surgery)
- chemotherapeutic response rate(after neoadjuvant CTx)
- overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death(2 years)
- disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first(2 years)