UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05148767
Phase
PHASE4
Status
Recruiting
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Conditions

  • Rectal Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant chemoradiotherapy based on irinotecan — DRUG
    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）.

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Dec 2021
Primary completion
Jun 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
606 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemoradiotherapy based on irinotecan
    Locally advanced rectal cancer patients who were treated with irinotecan-based neoadjuvant chemoradiotherapy regimen can be enrolled in this group.

Primary Outcome Measure

Complete remission rate [ Time Frame: 3 months after neoadjuvant chemoradiotherapy ]

Central Contacts

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