RecruitingAppendiceal CancerColorectal AdenocarcinomaPeritoneal Metastases
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
Eligible age
18–81 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Yale University
You may qualify if…
- ✓ 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 days prior to the first HIPEC
- ✓ Expected survival at the time of first HIPEC is greater than 3 months
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.
Where it's recruiting
Connecticut
New Haven
Source: ClinicalTrials.gov · NCT07291180 · last updated 2026-07-21