Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
NCT06210971 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-03-13
Summary
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
Conditions
Interventions
- DRUG
-
liposomal irinotecan
Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2
- DRUG
-
Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.
- RADIATION
-
Radiation threapy
50.4Gy/28 fractions
Sponsors & Collaborators
-
Hebei Medical University Fourth Hospital
lead OTHER
Principal Investigators
-
Fengpeng Wu, Professor · Hebei Medical University Fourth Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2026-02-01
- Completion
- 2028-07-01
Countries
- China
Study Locations
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