NCT06210971

Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

Exploratory Study on 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	liposomal irinotecan	Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2
DRUG	Capecitabine	Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.
RADIATION	Radiation threapy	50.4Gy/28 fractions

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2028-07-01
• First posted: 2024-01-18
• Last updated: 2025-03-13

Locations

1 site across 1 country: China