EUCTR2005-005945-20-DE进行中（未招募）不适用
Multicenter, open-label and randomized phase II study to evaluate safety and efficacy of the tri-functional bispecific antibody catumaxomab(anti-EpCAM x anti-CD3) in patients after curative resection of a confirmed gastric adenocarcinoma compared with surgery alone
Fresenius Biotech GmbH0 个研究点目标入组 70 人开始时间: 2006年3月2日最近更新:
适应症
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.Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- •3.Intended curative gastrectomy (en-bloc-R0-resection considering the standardized D2-schedule)
- •4.Serosal infiltration (T3/T4, N+/-, M0) or T2b, N+/-, M0 confirmed by immediate section with histopathologic assessment during surgery
- •5.Male or female at an age of 18 years or older
- •6.Karnofsky index >/= 70
- •7.Negative pregnancy blood test at screening in women with 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Presence of distant metastases
- •2.Macroscopic and microscopic*) residual tumor present after surgery
- •3.Pancreas resection (also partial) or thoracotomy
- •4.Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer
- •5.Previous treatment with non-humanized mouse or rat monoclonal antibodies
- •6.Known/suspected hypersensitivity to catumaxomab or similar antibodies
- •7.Any cancer disease or any cancer treatments within the last 5 years
- •8.Presence of constant immunosuppressive therapy within the last 28 days prior to
- •the first administration of catumaxomab
- •9.Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
- •10.Presence of symptomatic heart failure or occlusive arterial diseases
- •11.Inadequate renal function (Creatinine >1.5 x ULN),
- •12.Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin = 1.5 x ULN)
- •13.Platelets <75000 cells/mm3; absolute neutrophil count <1500 cells/mm3
- •14.Patient had a bowel obstruction within the last 30 days
- •15.Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
- •16.Presence of any acute or chronic systemic infection
- •17.Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
- •18.Patient is an employee of any involved study investigator or any involved institution including the study sponsor
- •19.Parallel participation in another clinical trial or previous participation in this study
- •20.Treatment with another investigational product during this study or during the last 30 days prior to study start
- •*): according to the results of the immediate section during surgery
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