Heated chemo drug tested for abdominal cancer spread
NCT ID NCT04761185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested the safety and tolerability of a chemotherapy drug called raltitrexed when given as a heated solution directly into the abdomen (HIPEC) in 30 patients with colorectal cancer. The goal was to find the highest safe dose and understand how the drug behaves in the body. The study is complete and will guide future research on this treatment approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Raltitrexed (a chemotherapy drug given as heated intraperitoneal chemotherapy)
- What this could lead to
- If successful, this could help determine a safe dose of raltitrexed for use in heated chemotherapy to control colorectal cancer spread in the abdomen.
- What could go wrong
- This is a very early (Phase 1) trial with only 30 participants, so results may not apply to all patients. The main goal is safety, not effectiveness, and there are risks of side effects from the chemotherapy.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Jun 2025
- Lead sponsor
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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
-
18 to 75 years
- Sex
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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: 1. Ages 18-75 (including 18 and 75), regardless of gender; 2. ECOG score ≤1; 3. Patients with colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma/mucinous tumor confirmed by histopathology; 4. The laboratory test results within 1 week before treatment meet the following conditions: White blood cell (WBC) ≥ 4.0×109 /L;Neutrophil count (ANC) ≥ 1.8×109 /L;Platelet (PLT) ≥ 100×109/L;Hemoglobin (Hb) ≥ 80 g/L;Serum total bilirubin (TB) ≤ 1.5×ULN;Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)≤ 2.5×ULN;Blood urea nitrogen (BUN) and blood creatinine (Cr) ≤ 1.5×ULN; 5. Patients voluntarily participate in this study, sign written informed consent, have good compliance and are willing to cooperate with the follow-up. Exclusion Criteria: 1. Patients with severe complications were considered to be intolerant of postoperative chemotherapy; 2. Previous or concurrent malignancy, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 3. Patients with peptic ulcer, gastrointestinal dynamic obstruction, severe active bleeding of the digestive tract, and perforation of the digestive tract; 4. Those with a history of allergy to the drug components or metabolites in the program; 5. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 6. had any heart disease, including :(1) angina;(2) Arrhythmia requiring medical treatment or clinically significant;(3) Myocardial infarction;(4) Heart failure;(5) any other heart disease deemed unfit to participate in this study by the researcher; 7. Female patients during pregnancy and lactation, female patients with fertility and positive test of baseline pregnancy or female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period; 8. The accompanying diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study; 9. A past history of neurological or mental disorders, such as major depression, epilepsy, or dementia, that clearly affect study disclosure or follow-up evaluation; 10. Participate in other clinical trials within 30 days of enrollment and receive research drugs and any concomitant treatment containing research drugs; 11. Other conditions in which the investigator considers it inappropriate to participate in this study.
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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
-
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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Other studies related to the condition(s) this trial covers.
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