Clinical trial NCT06789224: Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
Official title: Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Carcinoma
Prostate Tumor
Gallbladder Carcinoma
Endometrial Carcinoma
Gastric Carcinoma
Ovarian Carcinoma
Pancreatic Carcinoma
Colon Carcinoma
Non-small Cell Lung Cancer
Peritoneal Carcinomatosis
Kidney Carcinoma
Liver Carcinoma
Lead sponsor: Lindis Bloodcare GmbH
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: depletion of EpCAM-positive tumor cells
timeFrame: during surgery only
Secondary outcomes:
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH
state: NRW
city: Frankfurt
country: Germany
facility: Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Würzburg
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg
Study officials:
affiliation: University Köln Merheim
name: Markus Heiss, MD
role: STUDY_CHAIR
References: