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).
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
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.
Single group
Mass-based response testing (MRT)
DeviceTravera 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.
Feasibility of performing MRT to select and deliver personalized HIPEC
Feasibility is defined as the percentage of treatment naïve and pretreated patients who successfully receive drug screening results within one week of tissue sampling from at least one peritoneal biopsy. This means that the test has enough tumor cell viability and purity to come back with specific results indicating sensitivities of HIPEC drugs and does not give an inconclusive result (due to insufficient tissue sample).
Concordance of MRT Results
Defined as the percentage of patients who receive identical HIPEC recommendations (reflecting the best response to MRT) in both rounds of testing. Concordance will only be evaluated for the subset of patients who have received two biopsies and Travera screenings.
One Year Overall Survival (OS)
Overall survival of patients will be measured from two time points: From the diagnosis of peritoneal metastasis to death from any cause at the end of follow-up (1 year). From the first HIPEC procedure to death from any cause at the end of follow-up (1 year).
Percentage of participants with Perioperative and Postoperative Complications
Percentage of participants that experienced any perioperative or postoperative complications will be graded using the CTCAE version 5. Complications will be noted during hospitalization or within 30 days of each HIPEC procedure, and incidence will be measured separately for patients undergoing IHIPEC.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) mean score
A tool used to assess the quality of life in cancer patients. It contains 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact) 10. It is scored on a 4-point scale (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). The EORTC QLQ-C30 instrument also contains 1 global health status/QoL scale that uses a 7-point scale scoring with anchors (1 = very poor and 7 = excellent).
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Yale University
Lead sponsor
Travera Inc
Collaborator
