Actively Recruiting
Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis
Led by Yale University · Updated on 2026-03-04
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
T
Travera Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate mass-based response testing (MRT) to select personalized hyperthermic intraperitoneal chemotherapy (HIPEC) treatments for patients with peritoneal metastases from high-grade appendiceal adenocarcinomas and colorectal cancer. It focuses on patients with unresectable disease where standard surgery is not possible. The study explores whether MRT can help tailor chemotherapy to improve treatment outcomes in this setting. Participants will undergo MRT on tissue biopsies to identify the best chemotherapy drugs for their cancer. Those with unresectable disease will receive iterative HIPEC (IHIPEC), which includes multiple HIPEC treatments combined with systemic chemotherapy, spaced about six weeks apart. The first IHIPEC begins three weeks after laparoscopy, and this treatment approach is personalized based on MRT results. During the study, participants will have diagnostic laparoscopies and biopsies, followed by up to three cycles of IHIPEC. Researchers will assess treatment feasibility, tumor response, survival, complications, quality of life, and financial impact over 12 months. They will also monitor tumor cell characteristics and chemotherapy effectiveness using MRT. Regular questionnaires and clinical evaluations will track participants' progress throughout the study period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV appendiceal adenocarcinoma (moderately/poorly differentiated, and/or signet ring cell tumors) or colorectal adenocarcinoma
- Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary
- Limited or no extraperitoneal metastases; any extraperitoneal metastases must be limited, stable, and treatable
- Adequate organ function with screening labs performed within 30 days prior to first HIPEC
- Expected survival greater than 3 months at time of first HIPEC
- Exhibits unresectable disease (bowel or mesenteric involvement) or Peritoneal Cancer Index (PCI) greater than 19
- Adult aged 18 to less than 81 years at time of consent
- ECOG performance status score of 0-2
- Male participants must agree to use contraception during treatment and for at least 95 days after
- Female participants of childbearing age must not be pregnant or breastfeeding and agree to use contraception
- Provides written informed consent for the study
- Patients with less than 8 rounds of prior chemotherapy and no radiation, ablative procedures, or cytoreductive surgery may enter at second diagnostic laparoscopy step
You will not qualify if you...
- Positive urine pregnancy test within 3 days prior to treatment or randomization
- Known allergy to study medications
- Hypoxia with pulse oximeter reading less than 92% at rest or requiring supplemental oxygen
- Concurrent malignancy interfering with study aims, except certain skin or in situ carcinomas treated curatively
- Significant extraperitoneal metastasis
- Creatinine clearance less than 60 mL/min per Cockcroft-Gault formula
- Clinically significant cardiac disease including unstable angina, recent myocardial infarction, or advanced heart failure
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg)
- Moderate to severe hepatic impairment (Child-Pugh B or C)
- Psychiatric or substance abuse disorder interfering with study compliance
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Progressive disease after first 3 months of systemic chemotherapy prior to HIPEC
- Radiation, ablative procedures, cytoreductive surgery, or systemic therapy within 3 months of initial laparoscopy
- Active infection requiring systemic therapy
- Known active TB or COVID infection
- Immunodeficiency or recent systemic steroid/immunosuppressive therapy
- Poorly controlled HIV infection despite therapy
- Known active hepatitis B or C infection if required by local authority
- Inability to receive chemotherapy for medical or insurance reasons
- Requires emergency surgery due to bleeding, perforation, or obstruction
- Prior iterative intraperitoneal therapy
- Contraindication to chemotherapy of choice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 1 day
Participants undergo diagnostic laparoscopy and tissue biopsy to assess unresectable peritoneal metastases and collect samples for mass-based response testing (MRT).
1 visit (in-person)
Duration - Approximately 3 weeks
Participants wait approximately three weeks after the diagnostic laparoscopy for MRT results to determine the optimal personalized chemotherapy regimen.
No visits; waiting period
Duration - Approximately 18 weeks (three cycles with ~6 weeks between each)
Participants receive iterative hyperthermic intraperitoneal chemotherapy (IHIPEC) guided by MRT results, including HIPEC followed by systemic chemotherapy repeated three times with approximately 6 weeks between each HIPEC.
3 treatment visits (in-person) plus systemic chemotherapy visits
Duration - Up to 12 months post-treatment
Participants are monitored with assessments including quality of life and financial toxicity questionnaires every 3 months up to 12 months after the last IHIPEC treatment.
Quarterly visits for up to 12 months
Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
W
Wumi Jemiseye, MPH
R
Rodolfo N Molina, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here