Combat Ovarian Cancer Treatment (COCT)

Lead Participant: COMBAT MEDICAL LTD

Abstract

Ovarian cancer is the biggest gynaecological killer of women in the UK with around 7,500 women diagnosed each year. Current treatment includes extensive surgery and chemotherapy, however, only 46% of women diagnosed survive 5-years. It has been shown that administrating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) directly into the peritoneal cavity has a positive clinical benefit to the patient with regards to increased survival rate and reduced cancer recurrence. However, whilst HIPEC is clinically used during surgery, Normothermic Intraperitoneal Chemotherapy (NIPEC) is sparingly used outside of the operating theatre due to the inability of the patients to tolerate the treatment, infection and toxicity.

Combat Medical have developed a platform that enables chemotherapy to be administered into various body cavities. The system incorporates a unique heating and pump system which enables a very accurate flow rate, with minimal pressure, at the optimal temperature. The system will enable patients to receive a clinically superior administration of intraperitoneal cancer drugs, as well as systemic chemotherapy, through the use of a bespoke catheter, which is inserted into the patient during surgery and remains in situ for up to 6 months, with limited toxicity.

This project will build upon the Combat Modular Recirculation System (funded through an InnovateUK Innovation Loan) in combination with a unique long-term catheter.

The aim is to first validate the modular system within clinically relevant pig studies through Combat's collaboration with The University of Nottingham. Secondly, the system will be clinically tested via our partnership with James Cook University NHS Hospital, part of the South Tees NHS Foundation Trust and the Fundacion Jimenez Diaz. The platform will provide the first clinical solution for late-stage ovarian cancer patients where cancer has metastasised to the peritoneum. The design and modification of peritoneal catheters will be undertaken so as to enable the devices to remain in the patient for the required time (3-6 months) without any increased toxicity.

The combination of the two systems will provide the first in-clinic solution which enables the delivery of intraperitoneal chemotherapy to patients, outside of surgery, for up to 6 sessions over a period of 3-6 months.

The successful output of the project will be a unique intraperitoneal chemotherapy delivery system with preliminary clinical data, as a stepping stone to a larger clinical, trial prior to full clinical adoption. The overall benefit being the reduction of cancer-recurrence and significantly enhancing the 5-year survival rate of ovarian cancer patients.

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