Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

Sponsor
The First Affiliated Hospital of Nanchang University
Study ID
NCT06118762
Phase
PHASE4
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fruquintinib — DRUG
    Fruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death.

Study Details

To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy

Key Dates

First listed
Nov 7, 2023
Start date
Oct 20, 2023
Status verified
Nov 2023
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquintinib combined with Raltitrexed group
    Fruquintinib combined with Raltitrexed therapy

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death ]

Central Contacts

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