c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous...
This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous literature data, the PFS of the second-line treatment of CPT-11+C225 is about 4 months. This study assumes that the total PFS time of C225 can be extended to 7 months after the failure of second-line CPT-11 treatment compared with the direct second-line combination. , set ? = 0.05, ? = 0.2, the expected enrollment time is 2 years, the follow-up time is 1 year, the 10% sample shedding rate, the total sample size is about 60 cases per group, a total of 120 cases.
Tracking Information
- NCT #
- NCT04833036
- Collaborators
- Not Provided
- Investigators
- Not Provided
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