CompletedPhase 1

Raltitrexed in HIPEC

China30 participantsStarted 2020-09-18

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Patients voluntarily participate in this study, sign written informed consent, have good compliance and are willing to cooperate with the follow-up.

Exclusion criteria

✕. 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;
✕. 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;
✕. 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;
✕. 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;

What they're measuring

Occurrence of Dose limiting toxicity.

Timeframe: Within 21 days post-treatment

tolerable dose

Timeframe: Up to 21 days post-treatment

the recommended phase II dose (RP2D)

Timeframe: Through study completion, up to 2 years

Trial details

NCT IDNCT04761185

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-28

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