Individual Response to HIPEC for Peritoneal Carcinomatosis
This study is looking at how well Hyperthermic Intraperitoneal Chemotherapy (HIPEC) works for people with peritoneal carcinomatosis (cancer that has spread to the lining of the abdomen) from mesothelioma, ovarian, colorectal, or appendiceal cancers. Researchers want to see if they can predict how you will respond to HIPEC by testing your tumor tissue in a lab before your actual treatment. You might receive HIPEC with oxaliplatin, 5-fluorouracil, doxorubicin, or cisplatin, sometimes with sodium thiosulfate. The study will measure how much your tumor shrinks or dies (percent necrosis) and how much it grows (Ki-67) about four days after HIPEC. This study is for adults aged 18 to 120 who have confirmed peritoneal carcinomatosis and can undergo surgery.
- Study design
- This is an interventional study with a planned enrollment of 60 participants. The study aims to correlate lab test results with actual patient outcomes.
- What's involved
- You would undergo Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with specific chemotherapy drugs based on your assigned group. Your tumor tissue will be tested in the lab before your HIPEC treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measures of response to treatment are taken about 4 days after HIPEC.
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NCT04847063
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Recruiting
PHASE1Ages 18+InterventionalDiagnosticNational Cancer Institute (NCI)Government-funded
~60 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Sodium Thiosulfate5-FluorouracilOxaliplatinDoxorubicinHyperthermic Intraperitonial ChemotherapyCisplatin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the correlation between ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67
Measured over approx. 4 days post-HIPEC
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Andrew M Blakely, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI.
Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score.
Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:
Primary Histology: Appendiceal/Colorectal/Ovarian / PCI Cutoff for Eligibility: Total Score \< 20 (out of 39 possible points)
Primary Histology: Mesothelioma or atypical mesothelial proliferation / PCI Cutoff for Eligibility: Total Score \<= 30 (out of 39 possible points)
Age \>= 18 years.
ECOG performance status \<= 1 (Karnofsky \>= 80%).
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count \>= 1,000/mcL
Platelets \>= 75,000/mcL
Total bilirubin within \<=1.5x institutional upper limit of normal (ULN)
AST (SGOT)/ ALT (SGPT) \<= 3x institutional upper limit of normal (ULN), or \<= 5.0x ULN in participants with liver metastases (only)
Creatinine within normal institutional limits
Creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal calculated using eGFR.
Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.
Ability of participant to understand and the willingness to sign a written informed consent document.
Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .
Exclusion
Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.
Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.
Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.
History of allergic reactions attributed to platinum-containing compounds.
History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).
HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.
What this trial measures
- To determine the correlation between ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67approx. 4 days post-HIPEC
percent necrosis and Ki-67 scores will be obtained and used to determine the correlation between each measure by ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and by in vivo intra-operative HIPEC