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

NCT07291180 | Recruiting DMC FDA Device

• 1 other identifier: 2000038133
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Adenocarcinoma; Peritoneal Metastases; Appendiceal Cancer

Keywords

Appendiceal Cancer; Colorectal Adenocarcinoma; Peritoneal Metastases; Iterative Hyperthermic Intraperitoneal Chemotherapy (IHIPEC)

Outcome Measures

Primary Outcomes (1)

• 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).

  at end of study, up to 12 months

Secondary Outcomes (12)

• Concordance of MRT Results

  at end of study, up to 12 months

• One Year Overall Survival (OS)

  up to 12 months

• Percentage of participants with Perioperative and Postoperative Complications

  up to 12 months

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) mean score

  every 3 months post last IHIPEC, up to 12 months

• Change in Comprehensive Score for Financial Toxicity (COST)

  every 3 months post last IHIPEC, up to 12 months

Study Arms (1)

MRT

EXPERIMENTAL

Participants with high-grade appendiceal and colorectal peritoneal metastasis will receive MRT to select and deliver personalized HIPEC regimens to participants undergoing IHIPEC

Device: Mass-based response testing (MRT)

Interventions

Mass-based response testing (MRT) DEVICE

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.

MRT

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 days prior to the first HIPEC
• Expected survival at the time of first HIPEC is greater than 3 months
• Exhibits unresectable disease (bowel or mesenteric involvement) or PCI \> 19
• Demographics
• Adult patient at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.
• Has an ECOG performance status score of 0-2.
• Male Participants
• A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.
• Female Participants

You may not qualify if:

• 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.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• Has known significant extraperitoneal metastasis.
• Has creatine clearance \<60 mL/m\^2 per the Cockcroft-Gault formula
• Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.
• Has poorly controlled hypertension defined as SBP ≥150mmHg and/or DBP ≥90mmHg.
• Has moderate to severe hepatic impairment (Child-Pugh B or C).
• Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
• Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).
• Has progressive disease following the first 3 months of systemic chemotherapy prior to HIPEC who is not in a stable condition to continue with the trial.
• Prior/Concomitant Therapy
• Has received radiation, ablative procedures, cytoreductive surgery, or systemic therapy including chemotherapy to treat metastatic disease within 3 months of initial laparoscopy.

Sponsors & Collaborators

• Yale University: lead
• Travera Inc: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Appendiceal Neoplasms

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Kiran Turaga, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wumi Jemiseye, MPH

CONTACT

203-737-2073; wumi.jemiseye@yale.edu

Rodolfo N Molina, MD

CONTACT

203-737-2073; Rodolfo.molina@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with peritoneal metastasis from high-grade appendiceal and colorectal adenocarcinoma.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)