Scientists try to personalize heated chemo for stomach cancers
NCT ID NCT04847063
First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 10 times
Summary
This study looks at a treatment called HIPEC, where heated chemotherapy is washed inside the abdomen after surgery to remove tumors. Researchers want to see if lab-grown tumor models can predict how well the chemotherapy works. Sixty adults with cancers that have spread to the abdomen lining will take part. The goal is to find better ways to choose chemotherapy drugs for each person.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyperthermic intraperitoneal chemotherapy (HIPEC) with drugs like oxaliplatin, cisplatin, mitomycin C, 5-fluorouracil, and sodium thiosulfate
- What this could lead to
- If successful, this could help doctors choose the best chemotherapy drugs for each patient's abdominal tumors, potentially improving treatment outcomes.
- What could go wrong
- This is a very early Phase 1 study with only 60 participants. The lab models may not accurately predict real treatment response, and the approach may not lead to better outcomes for patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2021
- Expected to finish
-
Dec 2034
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * 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 OR --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 CRITERIA: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Appendiceal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?