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Feasibility Study of Mass-Based Response Drug Screening for Appendiceal and Colorectal Cancer with Peritoneal Metastasis

This study is looking at a new way to choose personalized chemotherapy for people with appendiceal or colorectal cancer that has spread to the lining of the abdomen (peritoneal metastasis). It uses a test called Mass-based Response Testing (MRT) on your tumor cells to see which chemotherapy might work best. The goal is to see if MRT can help doctors pick the right chemotherapy for a treatment called Hyperthermic Intraperitoneal Chemotherapy (HIPEC), which delivers heated chemotherapy directly into the abdomen. You might be able to join if you are between 18 and 81 years old and have specific types of appendiceal or colorectal cancer with peritoneal metastasis. This study aims to enroll 20 participants and will measure if using MRT to guide HIPEC is possible and practical.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it's randomized or blinded, or what phase it is.
What's involved
If you have unresectable disease, you will undergo MRT on tissue biopsies. Iterative HIPEC (IHIPEC) will be given three weeks after laparoscopy, repeated three times with about six weeks between each HIPEC.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at the end of the study, up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
NAAges 18–81InterventionalTreatment
Yale University
~20 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Mass-based response testing (MRT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of performing MRT to select and deliver personalized HIPEC
Measured over at end of study, up to 12 months

Conditions

Appendiceal Cancer
Colorectal Adenocarcinoma
Peritoneal Metastases

Explore related trials

Appendix CarcinomaColorectal Carcinoma

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Kiran Turaga, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Wumi Jemiseye, MPH
[email protected]
203-737-4475
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV
Limited or no extraperitoneal metastases (any of the below)
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
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.
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.
A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence). Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR.
In addition to the criteria above, if a patient has undergone less than 8 rounds of chemotherapy at another institution (prior to initial diagnostic laparoscopy) and has not undergone radiation, ablative procedures, or cytoreductive surgery, then they are still eligible to enter the study at the second diagnostic laparoscopy step

Exclusion

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.
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.
Has received radiation, ablative procedures, cytoreductive surgery, or systemic therapy including chemotherapy to treat metastatic disease within 3 months of initial laparoscopy.
Has an active infection requiring systemic therapy.
Has a known active TB/ COVID infection.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.
Has a known history of poorly controlled HIV infection despite anti-retroviral therapy.
Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \[qualitative\] is detected) infection that is poorly controlled.
Inability to receive chemotherapy due to medical/insurance reasons.
Requires emergency surgery due to bleeding, perforation, or obstruction.
Has undergone previous iterative intraperitoneal therapy.
Has contraindication to chemotherapy of choice.

What this trial measures

  • Feasibility of performing MRT to select and deliver personalized HIPECat end of study, up to 12 months

    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).