EUCTR2006-002727-16-DE进行中（未招募）不适用
Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma after neoadjuvant chemotherapy and intended curative resection - n.a.
Fresenius Biotech GmbH0 个研究点目标入组 70 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated informed consent
- •2. Male or female patient at an age of 18 years or older
- •3. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- •4. TNM-staging at screening of T2/T3/T4, N+/-, M0
- •5. Intended curative subtotal or total gastrectomy ('en-bloc'-R0-resection considering the standard D2-scheme)
- •6. Karnofsky index >= 70
- •7. Negative pregnancy blood test at screening but not more than 72 hours prior to the start of chemotherapy, for women of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer before End-of-Treatment visit (EOT = 1 month after last catumaxomab administration)
- •2. Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except cervix carcinoma in situ and adequately treated non-melanomatous skin cancer)
- •3. Previous use of non-humanized monoclonal mouse or rat antibodies
- •4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies or to any of the planned ECX chemotherapeutic drugs
- •5. Known dihydropyrimidine-dehydrogenase (DPDH) deficiency
- •6. Known contraindications to any of the planned ECX-chemotherapeutics
- •7. Presence of distant metastases
- •8. Presence of constant immunosuppressive therapy
- •9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
- •10. Presence of symptomatic pyloric stenosis (defined as excessive vomiting and weight loss > 10% within the last 3 months)
- •11. Presence of any acute or chronic systemic infection
- •12. Presence of a bowel obstruction within the last 30 days
- •13. Pre-existing heart failure > NYHA class II
- •14. Inadequate renal function (Creatinine >1.5 x ULN or Creatinine Clearance < 60 ml/min/kg according to the Cockroft Formula)
- •15. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 1.5 x ULN)
- •16. Inadequate bone marrow function with Platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3
- •17. Left ventricular ejection fraction (LVEF) below normal institutional ranges as measured by echocardiogram or any clinically significant abnormality detected by echocardiogram
- •18. Pregnant or nursing woman, or woman of childbearing potential who is not using an adequate and effective contraceptive method during the study and at least three months after the last i.p.-infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
- •19. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study
- •20. The patient planned to be enrolled is an employee of any involved study investigator or of any involved institution including the study sponsor
- •21. Parallel participation in another clinical trial or previously in this study
- •22. Treatment with another investigational product during this study or during the last 30 days prior to study start
研究者
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