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Raltitrexed in HIPEC

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04761185
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the dose limiting toxicity and maximum tolerated dose.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIPEC using Raltitrexed

Drug: Raltitrexed
Raltitrexed in HIPEC
Other Names:
  • HIPEC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. toxicity dose [1 year]

      to determine dose-limiting toxicity

    2. tolerable dose [1 year]

      to determine maximum tolerable dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fudan University
    ClinicalTrials.gov Identifier:
    NCT04761185
    Other Study ID Numbers:
    • HIPEC-RAL
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fudan University
    Colorectal Cancer
    Raltitrexed
    HIPEC
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Raltitrexed

    Study Results

    No Results Posted as of Feb 18, 2021