Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Sponsor
West China Hospital
Study ID
NCT06341296
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposome — DRUG
    70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.
  • 5-FU — DRUG
    5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
  • LV — DRUG
    400mg/m\^2, d1, 14 days per cycle, 8 cycles.
  • Bevacizumab — DRUG
    5mg/kg, d1, 14 days per cycle, 8 cycles.

Study Details

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Key Dates

Start date
Jun 30, 2024
Status verified
Aug 2024
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
    Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.

Primary Outcome Measure

Objective response rate [ Time Frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months ]

Central Contacts

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