EUCTR2010-024111-13-DE进行中（未招募）1 期
Explorative trial to investigate catumaxomab (anti-EpCAM x anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric adenocarcinomas prior to gastrectomy - Catumaxomab for peritoneal carcinomatosis in gastric cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •All patients treated in this trial must fulfil all of the following inclusion criteria:
- •Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewert’s classification)
- •Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
- •Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
- •Signed and dated informed consent before the start of specific protocol procedures.
- •Age > 18 years
- •ECOG Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •-Hemoglobin > 10.0 g/dl
- •-Leukocyte count >4.000/µl; absolute neutrophil count (ANC) >2.000/µl
- •-Platelet count >= 100.000/µl
- •-Total bilirubin < 1,5 times the upper limit of normal
- •-ALT and AST < 3 x upper limit of normal
- •-Alkaline phosphatase < 5 x ULN
- •-Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min.
- •The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Patients with any of the following characteristics do not qualify for the study:
- •Distant metastasis other than peritoneal seedings
- •Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
- •Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment
- •History of HIV infection or chronic hepatitis B or C
- •Active, clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •History of organ allograft
- •Patients undergoing renal dialysis
- •Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •Excluded therapies and medications, previous and concomitant:
- •Prior anti-cancer chemotherapy or immunotherapy.
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery
- •Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s understanding of the informed consent procedure, participation in the study or evaluation of the study results.
研究者
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