Actively Recruiting
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
Led by Yale University · Updated on 2026-03-04
20
Participants Needed
1
Research Sites
91 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 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
Official 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), colorectal adenocarcinoma, or suspected colon, small bowel, or appendiceal adenocarcinoma with unknown primary
- Limited or no extraperitoneal metastases; any extraperitoneal metastases must be limited, stable, and treatable
- Adequate organ function with screening labs within 30 days prior to first HIPEC
- Expected survival greater than 3 months at the time of first HIPEC
- Unresectable disease (bowel or mesenteric involvement) or Peritoneal Cancer Index (PCI) greater than 19
- Adults aged 18 to less than 81 years at informed consent
- ECOG performance status score of 0 to 2
- Male participants agree to use contraception during treatment and for at least 95 days after completion and refrain from sperm donation during this period
- Female participants of childbearing age who are not pregnant or breastfeeding and agree to use contraception
- Written informed consent provided by participant or legally acceptable representative
- Patients with less than 8 rounds of prior chemotherapy at another institution and no prior radiation, ablative procedures, or cytoreductive surgery may enter at second diagnostic laparoscopy step
You will not qualify if you...
- Positive urine or serum pregnancy test within 3 days prior to randomization or treatment
- Known allergy to study medications
- Hypoxia with pulse oximeter reading less than 92% at rest or need for supplemental oxygen
- Concurrent malignancy that may interfere with study aims (except certain skin or in situ carcinomas treated curatively)
- Significant extraperitoneal metastasis
- Creatine clearance less than 60 mL/m2
- Clinically significant cardiac disease including unstable angina, recent myocardial infarction within 6 months, or severe congestive 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 cooperation
- Inability to swallow oral medication or gastrointestinal disorder affecting absorption
- Progressive disease after first 3 months of systemic chemotherapy prior to HIPEC without stable condition
- Received radiation, ablative procedures, cytoreductive surgery, or systemic therapy within 3 months prior to initial laparoscopy
- Active infection requiring systemic therapy
- Known active tuberculosis or COVID infection
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days prior to first study dose
- Poorly controlled HIV infection
- Poorly controlled hepatitis B or C infection
- Inability to receive chemotherapy due to medical or insurance reasons
- Requires emergency surgery for bleeding, perforation, or obstruction
- Previous iterative intraperitoneal therapy
- Contraindication to chemotherapy of choice
AI-Screening
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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
CONTACT
R
Rodolfo N Molina, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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