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RECRUITING
NCT05148767
PHASE4

UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world.

Official title: Neoadjuvant Chemoradiation With Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer: A Real-Word Multi-center Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

606

Start Date

2022-01-01

Completion Date

2026-12-30

Last Updated

2021-12-08

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant chemoradiotherapy based on irinotecan

Patients with locally advanced rectal cancer treated with irinotecan-based chemoradiotherapy were enrolled in this study. The dose of irinotecan is determined by the genotype of UGT1A1.Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2 (UGT1A1\*28 and \*6 :6/7+GG or 6/6+GA) or 50mg/m2 (UGT1A1\*28 and \*6 :7/7+GG or 6/6+AA or 6/7+GA).

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China