Background and problem statement
Peritoneal cancer is an underappreciated but very serious clinical problem. Every year, more than a million people worldwide are confronted with this disease as a result of metastases from common tumors of the intestine, ovary or stomach. The inability to combat these metastases locally is a major obstacle in treatment. Oncologists are exploring techniques to apply chemotherapy locally, but the results of current methods are inadequate because the chemo quickly leaks from the abdominal cavity and the exposure, and therefore the effect, of the drug remains limited.
Research direction/proposed solution
TU/e and UPyTher have developed a hydrogel for use in the abdominal cavity. The hydrogel provides local and prolonged exposure of chemotherapy in the abdominal cavity, making the treatment more effective and safer. The partners want to use the hydrogel to develop a new treatment method for metastatic ovarian cancer.
Relevance
Women with ovarian cancer often suffer from vague symptoms, which means that the correct diagnosis is only made late when the disease has already spread seriously in the abdominal cavity. A group of patients may undergo surgery to remove tumors, but the disease will return within two years. Other patients cannot be helped by surgery: their average life expectancy is only 6 to 12 months, with quality of life rapidly decreasing in the last months due to accumulation of abdominal fluid and impaired digestion – eg blockage of the intestines. A safe, effective therapy against metastases has the potential to improve the lives of many ovarian cancer patients.
Research questions
Is the effectiveness of the treatment of metastatic ovarian cancer improved if the chemotherapy is packaged in a hydrogel and the local exposure of the drug can be prolonged?
Does the slow local release of chemotherapy lead to fewer side effects due to lower concentrations in the blood?
Research design
The project partners have previously developed a prototype for the treatment of metastatic colon cancer. However, for ovarian cancer a different type of chemotherapy must be used. In this project, a new combination of hydrogel and chemo is made and tested in animal studies to determine its effectiveness and safety. Afterwards there will be a prototype that can be used in first clinical studies within 2 to 3 years.
Expected outcomes
After the project, a candidate formulation (hydrogel-chemo combination) was developed for the treatment of metastatic ovarian cancer. This has increased effectiveness (tested in relevant disease models for ovarian cancer) in combination with improved safety (fewer side effects) than without the use of a hydrogel.
Description of steps needed to implement results
The candidate formulation will be further developed to initiate initial clinical studies. A first step is to find the optimal dose that can be safely administered in humans. Additional animal studies in pigs are required for this. In addition, production processes must be developed to produce the formulation with the right quality to start the first clinical studies (phase I dosing) in patients. After that, phase II and III studies can begin to demonstrate effectiveness in women.
2023-12-15 01:15:01
#Preclinical #development #chemohydrogel #locally #metastatic #ovarian #cancer
