Bladder Carcinoma, Colon Carcinoma, Endometrial Carcinoma, Gallbladder Carcinoma, Gastric Carcinoma, Kidney Carcinoma, Liver Carcinoma, Non-small Cell Lung Cancer, Ovarian Carcinoma, Pancreatic Carcinoma, Peritoneal Carcinomatosis, Prostate Tumor
Conditions
Brief summary
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.
Interventions
DEVICECATUVAB
inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates
Sponsors
Lindis Bloodcare GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| depletion of EpCAM-positive tumor cells | 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 |
Countries
Germany
Outcome results
None listed