Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer

Sponsor
West China Hospital
Study ID
NCT06341309
Phase
PHASE1/PHASE2
Status
Not Yet 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. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
  • Bevacizumab — DRUG
    5mg/kg, d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).

Study Details

To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer.

Key Dates

Start date
Aug 9, 2024
Status verified
Aug 2024
Primary completion
Apr 1, 2026
Completion
Aug 1, 2026

Study Design

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

Arms

  • Experimental: irinotecan liposome injection combined with bevacizumab
    Patients will be treated with irinotecan liposome injection combined with bevacizumab. Treatment until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).

Primary Outcome Measure

Progression free survival -1 [ Time Frame: From initial medication to the date of first documented progression or end of medication, whichever came first . Assessed up to 18 months. ]

Central Contacts

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