NCT07291180

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 undergo MRT on tissue biopsies to determine optimal chemotherapy regimen to be delivered intraperitoneally. For patients with unresectable disease, iterative HIPEC (IHIPEC) will be administered starting three weeks after the laparoscopy. (IHIPEC refers to HIPEC followed by systemic chemotherapy repeated 3 times with approximately 6 weeks in between each HIPEC.)

Conditions

• Appendiceal Cancer
• Colorectal Adenocarcinoma
• Peritoneal Metastases

Interventions

Type	Name	Description
DEVICE	Mass-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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-12-18
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study