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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210971 on ClinicalTrials.gov