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RECRUITINGPhase 4INTERVENTIONAL

UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

Neoadjuvant Chemoradiation With Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer: A Real-Word Multi-center Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Pathologically confirmed rectal adenocarcinoma 2. Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT. 3. Without distance metastases 4. A need for tumor withdrawal. 5. Aged 18-75 years old, regardless of gender. 6. ECOG score 0-2. 7. Detection of UGT1A1\*6 and \* 28 gene status. 8. Be able to comply with the plan during the study period. 9. Sign the inform consent Who Should NOT Join This Trial: 1. Pregnant or breastfeeding women 2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ 3. 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 willing to sign a consent form or affect the patient's oral medication compliance. 4. 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 5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases 6. Subject blood routine and biochemical indicators do not meet the following criteria: blood count (hemoglobin) at least 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L 7. Anyone who is allergic to any research medication 8. DPD deficiency Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Pathologically confirmed rectal adenocarcinoma 2. Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT. 3. Without distance metastases 4. A need for tumor withdrawal. 5. Aged 18-75 years old, regardless of gender. 6. ECOG score 0-2. 7. Detection of UGT1A1\*6 and \* 28 gene status. 8. Be able to comply with the plan during the study period. 9. Sign the inform consent Exclusion Criteria: 1. Pregnant or breastfeeding women 2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ 3. 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. 4. 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 5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases 6. Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L 7. Anyone who is allergic to any research medication 8. DPD deficiency

Treatments Being Tested

DRUG

Neoadjuvant chemoradiotherapy based on irinotecan

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).

Locations (1)

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China