New hope for Stomach-Lining cancer: direct chemo attack
NCT ID NCT06269978
First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This early-phase trial tests whether giving two standard chemotherapy drugs (5FU and oxaliplatin) directly into the abdominal cavity is safe for people with colorectal cancer that has spread only to the peritoneal lining. About 24 adults will receive the drugs through a catheter during a short procedure. The main goals are to find the best dose and check for side effects. If safe, this approach might deliver stronger treatment to the cancer while reducing whole-body side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluorouracil and oxaliplatin
- What this could lead to
- If this works, it could offer a new way to deliver chemotherapy directly to the abdomen, potentially controlling cancer spread in the peritoneum with fewer side effects.
- What could go wrong
- This is a very early (Phase I) trial with only 24 people, focused on safety and dosing. It may not show strong anti-cancer effects, and there are risks from the drugs and procedures.
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
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9 people
The number who actually took part.
- Started
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Dec 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Age \>= 18 years * Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician * Primary colorectal cancer may either be left in place or have been resected prior to study enrollment * Patients are allowed to have received prior colorectal cancer-directed systemic therapy. * Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment * Absolute neutrophil count (ANC) ≥ 1,500 /mcL * Platelets ≥ 100,000 / mcL * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) * Creatinine clearance should be calculated per institutional standard * Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Both values must be in the specified range * Albumin \>= 2.5 g/dL * International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures * Anticipated life expectancy of ≥ 6 months * Willing to comply with study procedures * Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication * For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment * Be willing and able to understand and sign the written informed consent document * Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial * Be willing to provide peripheral blood and peritoneal samples for correlative studies Exclusion Criteria: * Patients who are receiving any other investigational drugs * Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging * Patients with primary mucinous appendiceal tumors will not be eligible. These tumors often produce mucin, which may affect the penetration of IP chemotherapy. Patients with non-mucinous appendiceal adenocarcinomas will be eligible. * Patients with \>= grade 2 peripheral neuropathy * Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements * Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration * Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C * Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Pregnancy or breastfeeding * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician
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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.
Contacts and locations
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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UT Southwestern/Simmons Cancer Center
Dallas, Texas, 75390, United States
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