Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
- Sponsor
- Hebei Medical University Fourth Hospital
- Study ID
- NCT06184698
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- liposomal irinotecan — DRUGliposomal irinotecan 70 mg/m²
- 5-FU — DRUG5-FU 2400 mg/m²
- LV — DRUG5-FU 2400 mg/m²
- Bevacizumab — DRUGbevacizumab 5 mg/kg
Study Details
This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.
Key Dates
- Start date
- Jan 1, 2024
- Status verified
- Sep 2024
- Primary completion
- Feb 1, 2026
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 173 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental Groupliposomal irinotecan+5-FU/LV+ bevacizumab q2w
Primary Outcome Measure
Objective Response Rate [ Time Frame: 4 months ]
Central Contacts
- Xuhua Hu, Doctor0311-86095347
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