Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT05148767

UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Led by Zhejiang Cancer Hospital · Updated on 2021-12-08

606

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed rectal adenocarcinoma
  • Clinical stage T3-4 and/or positive lymph nodes, with planned neoadjuvant chemoradiotherapy
  • No distant metastases
  • Tumor requires removal
  • Age between 18 and 75 years, any gender
  • ECOG performance status of 0 to 2
  • UGT1A1*6 and *28 gene status tested
  • Ability to follow the study plan during the trial
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of other malignant diseases in past 5 years except cured skin cancer or cervical carcinoma in situ
  • Uncontrolled epilepsy, central nervous system disease, or mental disorder affecting consent or medication compliance
  • Severe active heart disease, including symptomatic coronary heart disease, NYHA class II or higher heart failure, serious arrhythmia, or recent myocardial infarction
  • Organ transplant recipients on immunosuppressive therapy
  • Severe uncontrolled infections or other serious uncontrolled diseases
  • Blood and biochemical values outside specified limits: hemoglobin <90 g/L, ANC <1.5 x 10^9/L, ALT or AST >2.5 times normal, ALP >2.5 times normal, bilirubin >1.5 times normal, creatinine > normal limit, albumin <30 g/L
  • Allergy to any study medication
  • DPD deficiency

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

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

J

Ji Zhu, MD

CONTACT

Q

Quanquan Sun, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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