Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
NCT06341296 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2024-08-12
Summary
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.
Conditions
Interventions
- DRUG
-
Irinotecan Liposome
70 mg/m\^2 , d1, 14 days per cycle, 8 cycles.
- DRUG
-
5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
- DRUG
-
LV
400mg/m\^2, d1, 14 days per cycle, 8 cycles.
- DRUG
-
5mg/kg, d1, 14 days per cycle, 8 cycles.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2026-04-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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