Actively Recruiting
Feasibility Study of Personalized Hyperthermic Intraperitoneal Chemotherapy Guided by Mass-Based Response Testing for High-Grade Appendiceal and Colorectal Cancer with Peritoneal Metastasis
Led by Yale University · Updated on 2026-07-21
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
Researchers are evaluating mass-based response testing MRT to guide personalized hyperthermic intraperitoneal chemotherapy HIPEC for patients with peritoneal metastases from high-grade appendiceal adenocarcinomas and colorectal cancer. This study aims to improve treatment selection for patients who have unresectable disease or extensive cancer spread within the abdomen. The study evaluates whether MRT can help choose effective chemotherapy drugs tailored to the individual patients tumor. Participants with unresectable peritoneal metastases will have tissue biopsies tested with MRT to identify optimal chemotherapy drugs. Those with unresectable disease will receive iterative HIPEC IHIPEC, which combines repeated cycles of heated chemotherapy delivered inside the abdomen with systemic chemotherapy. The IHIPEC cycles start about three weeks after laparoscopy and are repeated approximately three times with six weeks between each treatment. During the study, participants will be monitored for up to 12 months. Researchers will assess the feasibility of using MRT to select personalized HIPEC regimens, overall survival, treatment complications, quality of life, financial impacts, tumor response, and chemotherapy delivery success. Assessments include tissue biopsies, laparoscopy, laboratory tests, and questionnaires every three months. This detailed monitoring helps evaluate the treatment process and its effects over time.
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), colorectal adenocarcinoma, or suspected colon, small bowel, or appendiceal adenocarcinoma of unknown primary
- Limited or no extraperitoneal metastases; any present must be limited, stable, and treatable
- Adequate organ function based on screening labs 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 informed consent
- ECOG performance status score of 0-2
- Male participants agree to use contraception during treatment and for at least 95 days after
- Female participants of childbearing age are not pregnant, not breastfeeding, and agree to use contraception
- Provides written informed consent
- Patients with fewer than 8 rounds of prior chemotherapy (and no prior 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 start
- Known allergy to study medications
- Hypoxia with pulse oximeter <92% at rest or need for supplemental oxygen
- Concurrent malignancy that may interfere with study aims
- Significant extraperitoneal metastasis
- Creatinine clearance below 60 mL/min/m2
- Clinically significant cardiac disease including unstable angina, recent myocardial infarction, or severe heart failure
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg)
- Moderate to severe liver impairment (Child-Pugh B or C)
- Psychiatric or substance abuse disorders interfering with study cooperation
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Progressive disease after first 3 months of systemic chemotherapy prior to HIPEC and unstable condition
- Radiation, ablative procedures, surgery, or systemic therapy within 3 months prior to initial laparoscopy
- Active infection requiring systemic therapy
- Known active TB or COVID infection
- Immunodeficiency or recent immunosuppressive therapy
- Poorly controlled HIV, HBV, or HCV infections
- Inability to receive chemotherapy due to medical or insurance reasons
- Requires emergency surgery for bleeding, perforation, or obstruction
- Prior iterative intraperitoneal therapy
- Contraindications to chemotherapy of choice
Research Team
W
Wumi Jemiseye, MPH
R
Rodolfo N Molina, MD
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