ISRCTN53770195已完成2 期
Multicentre, open-label phase II study to evaluate the efficacy of a two cycle immunotherapy with the trifunctional bispecific antibody catumaxomab (anti EpCAM x anti-CD3) in addition to systemic chemotherapy in patients with peritoneal carcinomatosis from gastric or colorectal adenocarcinoma
niversity of Witten/Herdecke (Germany)0 个研究点目标入组 40 人开始时间: 2011年10月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patient aged 18 years or older
- •2. Signed and dated informed consent
- •3. Patient has peritoneal carcinomatosis of colorectal or gastric adeno-carcinoma (histologically confirmed)
- •4. Eastern Cooperative Oncology Group (ECOG) status 1 or 2 (Karnofsky index >= 70)
排除标准
- •1. Symptomatic ascites (estimated accululation of more than 1500 ml by sonography and computer tomography and puncture of more than 1500 ml)
- •2. Ileus or abdominal obstruction with the need of surgical intervention at inclusion or parenteral feeding (> 30% of daily calorie intake)
- •3. Previous use of non-humanised monoclonal mouse or rat antibodies
- •4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies
- •5. Presence of any acute or chronic systemic infection
- •6. Pre-existing heart failure > New York Heart Association (NYHA) class II
- •7. Pregnancy or breast feeding
- •8. Other concurrent uncontrolled medical conditions
- •9. Previous Catumaxomab therapy
- •10. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
- •11. Inadequate renal function (Creatinine > 1,5 x ULN)
- •12. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 2 x ULN)
- •13. Inadequate bone marrow function with platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3 or a proportion of < 15% of lymphocytes in differential blood count
- •14. 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)
- •15. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study
- •16. Parallel participation in another clinical trial or previously in this study
- •17. Treatment with another investigational product during this study or during the last 30 days prior to study start (day 0)
- •18. Under no circumstances must a patient be enrolled in this study more than once
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