Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 12
- 主要终点
- depletion of EpCAM-positive tumor cells
研究概览
简要总结
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intraoperative blood salvage (IBS)-eligible according to the Investigator
- •Patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being EpCAM-positive (>92%) OR kidney carcinoma or liver carcinoma.
- •For patients with cancer types with a high likelihood of being EpCAM-positive (>92%): if a tumor tissue sample is available and has been EpCAM tested or EpCAM-testing can be done within 5 days of signing the informed consent form (ICF): results of EpCAM typing should be positive.
- •For patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested EpCAM-positive prior to surgery.
- •Scheduled for surgery to remove tumor.
- •The Investigator expects that at least 400 mL full blood can be collected during the tumor surgery.
- •An American Society of Anesthesiologists (ASA) Classification of ≤3.
排除标准
- •Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
- •Lymphocytopenia (count <1.0 x 109 /L lymphocytes).
- •Cancer different from indicated types, especially typically EpCAM-negative tumor types.
- •Sepsis occurring during surgery.
- •Cirrhosis of the liver with a Child-Pugh score of C.
- •A thrombocyte count of <30.000/µL.
- •Allergies and/or contraindications against Catumaxomab or any of the components or ingredients used in the IBS procedure (e.g., leukocyte depletion filter [LDF], diluent, buffer solution or anticoagulants).
- •Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.
结局指标
主要结局
depletion of EpCAM-positive tumor cells
时间窗: during surgery only
Tumor cell count (Depletion) measured with Immun-histo chemistry staining and tumor cell counting in a Neubauer Chamber * a depletion to ≤10 cells per 100 mL EC, OR * if \<100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 103 in the EC (total) as compared to collected intraoperative blood (total), OR * if ≥100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 5x103 in the EC (total) as compared to collected intraoperative blood (total), in at least 95% of subjects after one IBS/LDF cycle using the Catuvab device. The primary endpoint will only be determined in subjects with EpCAM-positive tumor cells in salvaged blood and who receive retransfusion of the EC
次要结局
未报告次要终点