Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06210971

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

Led by Hebei Medical University Fourth Hospital · Updated on 2025-03-13

60

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • ECOG performance status of 0 to 1
  • Histopathologically confirmed rectal adenocarcinoma
  • Primary tumor located below the peritoneal reflection or within 10 cm of the anal verge
  • Clinical stage T3-4NanyM0 or T1-2N+M0
  • Adequate bone marrow function: ANC 61.5�d710^9/L, Platelets 61100�d710^9/L, Hemoglobin 6590 g/L
  • Adequate liver function: Total bilirubin 641.5 times ULN, AST and ALT 642.5 times ULN, Serum albumin 653 g/dL
  • Adequate kidney function: Serum creatinine 641.5 times ULN or creatinine clearance 6560 mL/min
  • Willingness to undergo UGT1A1 gene testing with genotype 11 or 128
  • Agreement to follow the neoadjuvant chemoradiotherapy protocol and provide informed consent
Not Eligible

You will not qualify if you...

  • Any other malignancy within the past 5 years except cured in-situ carcinoma or basal cell carcinoma
  • Active, uncontrolled infections requiring systemic treatment
  • Active HIV infection
  • Uncontrolled systemic diseases
  • History of allergy or hypersensitivity to the study drugs or their components
  • Contraindications to radiotherapy, chemotherapy, or surgery
  • Use of strong CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers
  • Pregnant or breastfeeding women, or those of childbearing age refusing contraception
  • Patients with poor cognitive ability or mental disorders preventing questionnaire completion
  • Patients judged by the investigator to be unsuitable despite meeting inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China, 050000

Actively Recruiting

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Research Team

L

Linlin Xiao, Ms.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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