Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device (REMOVE)

Lindis Bloodcare GmbH

Status

Completed

Conditions

Colon Carcinoma

Prostate Tumor

Bladder Carcinoma

Liver Carcinoma

Ovarian Carcinoma

Gallbladder Carcinoma

Endometrial Carcinoma

Gastric Carcinoma

Non-small Cell Lung Cancer

Kidney Carcinoma

Peritoneal Carcinomatosis

Pancreatic Carcinoma

Treatments

Device: CATUVAB

Study type

Interventional

Funder types

Industry

Identifiers

NCT06789224

REMOVE

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.