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NCT04761185CompletedPhase 1

Raltitrexed in HIPEC

Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the safety, tolerability, PK, and efficacy.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (actual)
First submitted
5 Jan 2021
Start date
18 Sept 2020
Primary completion date
28 Dec 2024
Lead sponsor
Fudan University
NCT number
NCT04761185

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 30
  • From 18 Sept 2020 to the primary completion date, 28 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with severe complications were considered to be intolerant of postoperative chemotherapy;
  • 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;
  • Participate in other clinical trials within 30 days of enrollment and receive research drugs and any concomitant treatment containing research drugs;

Other illness

  • Patients with peptic ulcer, gastrointestinal dynamic obstruction, severe active bleeding of the digestive tract, and perforation of the digestive tract;
  • Those with a history of allergy to the drug components or metabolites in the program;
  • A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • 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;
  • 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;
  • A past history of neurological or mental disorders, such as major depression, epilepsy, or dementia, that clearly affect study disclosure or follow-up evaluation;
  • Other conditions in which the investigator considers it inappropriate to participate in this study.

Age

  • 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;

Who the study is looking for

  • Ages 18-75 (including 18 and 75), regardless of gender;
  • ECOG score ≤1;
  • Patients with colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma/mucinous tumor confirmed by histopathology;
  • 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;
  • Patients voluntarily participate in this study, sign written informed consent, have good compliance and are willing to cooperate with the follow-up.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.