A Feasibility Study of Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis
Yale University
Summary
This study will evaluate the role of mass-based response testing (MRT) to select and deliver personalized hyperthermic intraperitoneal chemotherapy (HIPEC) regimens to patients with peritoneal metastasis (PM) from high-grade appendiceal adenocarcinomas (HGAA) and colorectal cancer (CRC).
Description
Patients with peritoneal metastases from colorectal and appendix cancer are treated with cytoreductive surgery and HIPEC. However, several patients are considered unresectable due to the inability to remove all the cancer safely. Repeated (Iterative) intra-peritoneal chemotherapy delivered via HIPEC laparoscopically has been shown to have favorable outcomes with a potential increase in sensitivity to immunotherapy . Such procedures often use chemotherapy that is not tailored to the patients cancer. In this study, patients with unresectable colorectal and appendiceal peritoneal metastases will…
Eligibility
- Age range
- 18–81 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV 1. Appendiceal adenocarcinoma (moderately/poorly differentiated, and/or signet ring cell tumors) 2. Colorectal adenocarcinoma 3. Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary * Limited or no extraperitoneal metastases (any of the below) a) Any extraperitoneal metastases must be limited, stable and treatable * Has adequate organ function, as described below; all screening laboratory tests should be performed within 30…
Interventions
- DeviceMass-based response testing (MRT)
Travera has developed a clinical workflow that combines single-cell mass measurements with inline brightfield imaging and machine-learning based image classification to perform mass-based response testing (MRT) directly on live tumor cells collected from patients. MRT enables tumor cells across a wide range tissue sample formats to be dosed with a panel of drugs in vitro, agnostic to malignancy or drug mechanism.
Location
- Yale New Haven HospitalNew Haven, Connecticut