[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450690":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":50,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant chemoradiotherapy based on irinotecan","EXPERIMENTAL","Locally advanced rectal cancer patients who were treated with irinotecan-based neoadjuvant chemoradiotherapy regimen can be enrolled in this group.",[13],"Drug: Neoadjuvant chemoradiotherapy based on irinotecan",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","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:\n\nRadiation: 50Gy\u002F25Fx; Capecitabine: 625mg\u002Fm2 bid Monday-Friday per week; Irinotecan: 80mg\u002Fm2 (UGT1A1\\*28 and \\*6: 6\u002F6+GG) or 65mg\u002Fm2 (UGT1A1\\*28 and \\*6 ：6\u002F7+GG or 6\u002F6+GA) or 50mg\u002Fm2 （UGT1A1\\*28 and \\*6 ：7\u002F7+GG or 6\u002F6+AA or 6\u002F7+GA）.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Ji Zhu, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":22,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","571-88128142","+86","leo.zhu@126.com",{"name":31,"role":26,"phone":27,"phoneExt":28,"email":32},"Quanquan Sun, MD","sunqq@zjcc.org.cn",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.16142,30.29365,{"lat":44,"lon":43},[47,48],{"name":22,"role":26,"phone":27,"phoneExt":28,"email":29},{"name":31,"role":26,"phone":49,"phoneExt":28,"email":32},"571-88128212",{"type":23,"investigatorFullName":22,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Chief physician","100450690","phase-4-ugt1a1-based-irinotecan-therapy-for-locally-advanced-rectal-cancer-100450690",false,"NCT05148767","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","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma\n2. Clinical stage T3-4 and \u002F or Nude positive, and the treatment plan is nCRT.\n3. Without distance metastases\n4. A need for tumor withdrawal.\n5. Aged 18-75 years old, regardless of gender.\n6. ECOG score 0-2.\n7. Detection of UGT1A1\\*6 and \\* 28 gene status.\n8. Be able to comply with the plan during the study period.\n9. Sign the inform consent\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ\n3. 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.\n4. 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\n5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases\n6. Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g \u002F L; absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002F 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 \\\u003C1.5 times the normal upper limit; serum creatinine \\\u003C1 times the normal upper limit; serum albumin ≥ 30g \u002F L\n7. Anyone who is allergic to any research medication\n8. DPD deficiency","ALL","18 Years","75 Years",{"count":63,"type":64},606,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","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.",[70],"Rectal Cancer Stage III",[72,73,74],"locally advanced rectal cancer","Neoadjuvant chemoradiotherapy","irinotecan","2021-12-07",{"date":77,"type":78},"2021-12-08","ACTUAL",{"date":80,"type":64},"2022-01-01",{"date":82,"type":64},"2026-12-30",{"name":5,"class":6},1]