Raltitrexed in HIPEC

NCT04761185 | Completed Phase 1 DMC

• 1 other identifier: HIPEC-RAL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer; Raltitrexed; HIPEC

Keywords

Colorectal Cancer; Raltitrexed; HIPEC

Outcome Measures

Primary Outcomes (3)

• Occurrence of Dose limiting toxicity.

  to determine dose-limiting toxicity

  Within 21 days post-treatment

• tolerable dose

  to determine maximum tolerable dose

  Up to 21 days post-treatment

• the recommended phase II dose (RP2D)

  The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings.

  Through study completion, up to 2 years

Secondary Outcomes (5)

• Maximum concentration (Cmax)

  Up to 48 hours after administration

• Time to maximum concentration (Tmax)

  Up to 48 hours after administration

• Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)

  Up to 48 hours after administration

• Recurrence-free survival (RFS)

  Up to 2 years

• Apparent volume of distribution (Vz/F) and clearance (CLz/F)

  Up to 48 hours after administration

Study Arms (1)

HIPEC using Raltitrexed

EXPERIMENTAL

Drug: Raltitrexed

Interventions

Raltitrexed DRUG

The RTX-HIPEC protocol used classical 3+3 dose-escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2)

Also known as: HIPEC

HIPEC using Raltitrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• A past history of neurological or mental disorders, such as major depression, epilepsy, or dementia, that clearly affect study disclosure or follow-up evaluation;
• Participate in other clinical trials within 30 days of enrollment and receive research drugs and any concomitant treatment containing research drugs;
• Other conditions in which the investigator considers it inappropriate to participate in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

raltitrexed; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Model Details: Employing a standard 3+3 dose-escalation design, RTX was administered at doses ranging from 3 to 9 mg/m2 during HIPEC.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: February 18, 2021
• Study Start: September 18, 2020
• Primary Completion: December 28, 2024
• Study Completion: June 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2025-05

Locations

CN (1)