UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
ConditionRectal Cancer Stage III
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Pathologically confirmed rectal adenocarcinoma
Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT.
Without distance metastases
A need for tumor withdrawal.
Disqualifiers
Pregnant or breastfeeding women
Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
Trial design
Treatments tested in this trial
- Neoadjuvant chemoradiotherapy based on irinotecan
Treatment groups
606 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov