A Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients

Sponsor
China Medical University, China
Study ID
NCT06169202
Status
Unknown

Conditions

  • Capecitabine
  • Fruquintinib
  • Gastrointestinal Tumours
  • Irinotecan

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • fruquintinib — DEVICE
    4 mg orally once daily, D1-14, repeated every 3 weeks.
  • Irinotecan — DRUG
    180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1\*28 and \*6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation).
  • Capecitabine — DRUG
    1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks.

Study Details

This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer.

Key Dates

Start date
Jun 1, 2023
Status verified
Dec 2023
Primary completion
Apr 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Fruquintinib in combination with irinotecan and capecitabine
    Phase I: Treatment phase: 6-8 cycles (as determined by the researcher) 1. Irinotecan: 180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1\*28 and \*6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation). 2, Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks. 3. Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. Phase II: Maintenance phase: 1, Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. 2. Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: one year ]

Central Contacts

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