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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-81
SponsorYale University

About this trial

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).

Eligibility criteria

Qualifiers

Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV

Appendiceal adenocarcinoma (moderately/poorly differentiated, and/or signet ring cell tumors)

Colorectal adenocarcinoma

Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary

Disqualifiers

Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Has a known allergy to medications used in this study. Note: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.

Has hypoxia as defined by pulse oximeter reading <92% at rest or requires intermittent or chronic supplemental oxygen.

No concurrent malignancy that may interfere with the study aims at the discretion of the investigator.

Trial design

Treatments tested in this trial

  • Mass-based response testing (MRT)

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yale University

Lead sponsor

Travera Inc

Collaborator