2cureX Receives Ethical Approval for Groundbreaking HIPEC Clinical Trial

December 6 | 2023

2cureX, a company pioneering the use of 3D tumoroids for drug sensitivity prediction in patients with cancer, is pleased to announce the approval from the Ethical Committee at Fundación Jimenez Diaz in Madrid to start a clinical trial using IndiTreat® in Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in metastatic colorectal cancer patients. An IndiTreat® test for this innovative treatment approach will bring additional value to 2cureX’s ZENITH project for enabling in-house IndiTreat® testing at hospital sites.

Understanding HIPEC
HIPEC (short for hyperthermic intraperitoneal chemotherapy) is an advanced treatment procedure designed to address cancer metastases in the abdomen. HIPEC procedures comprise the rinsing of the abdominal cavity with heated chemotherapy solutions after surgery. This targeted approach allows for higher local concentrations of chemotherapy with the intention to maximize effectiveness while minimizing systemic side effects.

This treatment is primarily offered to patients with cancers originating in the abdominal area, including colorectal cancer, gastric cancer, ovarian cancer, and mesothelioma. HIPEC approaches have shown promising results in increasing survival rates and improving the quality of life for patients with these challenging diagnoses.

In this prospective trial, 2cureX’s IndiTreat® tests will identify the cytotoxic drug that has the most promising efficacy profile on an individual HIPEC patient’s tumor.

IndiTreat® contribution to HIPEC
“This is a very important study. HIPEC is a promising approach, but we need to standardize the assessment of which patients it should be offered to, and which drugs we should use on each of them”, said Dr. Jesus Garcia-Foncillas, MD, PhD, Director of the University Cancer Institute and the Department of Oncology at University Hospital Fundación Jimenez Diaz in Madrid. Dr. Pedro Villarejo, MD, PhD, Associate Head of General Surgery at the same hospital added: “We expect that the IndiTreat® test can provide valuable information to select the right patients.”. Both doctors are the Principal Investigators in the study.

A brand-new segment for IndiTreat®
This study opens the possibility of a brand-new group of patients that could benefit from IndiTreat®” stated Raphael Gruber, Medical Director of 2cureX. "We are proud to partner with the University Hospital Fundación Jimenez Diaz as one of the leading European reference centers in HIPEC”.

2cureX announced recently its ZENITH project, a full focus on making IndiTreat® testing available at hospitals worldwide by accelerating the development of an automated IVD system. The HIPEC application of IndiTreat® is expected to be part of the upcoming IVD-R decentralized drug testing platform.