[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411321":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":51,"collaborators":54,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":20,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":20,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Sintilimab+Hypofractionated radiotherapy",[13,14],"Drug: Sintilimab","Radiation: Hypofractionated Radiotherapy",[16,21],{"type":17,"name":18,"description":11,"armGroupLabels":19,"otherNames":20},"DRUG","Sintilimab",[9],null,{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":20},"RADIATION","Hypofractionated Radiotherapy",[9],[26],{"name":27,"affiliation":5,"role":28},"Meng Qiu, M.D.","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":20,"email":33},"CONTACT","+86-28-85422589","hxqmtg@163.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"West China Hospital of Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":44,"coordinates":45},"Point",[46,47],104.06667,30.66667,{"lat":47,"lon":46},[50],{"name":27,"role":31,"phone":32,"phoneExt":20,"email":33},{"type":28,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Meng Qiu","Prof.",[55,57,59,61,64],{"name":56,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":58,"class":6},"Yunnan Cancer Hospital",{"name":60,"class":6},"Sichuan Cancer Hospital and Research Institute",{"name":62,"class":63},"Chengdu Third People's Hospital","UNKNOWN",{"name":65,"class":6},"The Affiliated Hospital Of Southwest Medical University","100411321","phase-1-sintilimab-plus-hypofractionated-radiotherapy-for-msi-hdmmr-rectal-cancer-100411321",false,"NCT04636008","Sintilimab Plus Hypofractionated Radiotherapy for MSI-H\u002FdMMR Rectal Cancer","The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H\u002FdMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study","Inclusion Criteria:\n\n1. Histologically confirmed rectal adenocarcinoma;\n2. With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;\n3. Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;\n4. No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；\n5. Men and women ≥18 years of age;\n6. Eastern Cooperative Oncology Group performance status score 0 or 1;\n7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: hemoglobin ≥90 g\u002FL, neutrophils ≥1500\u002Fmm3, platelets ≥75,000\u002Fmm3; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.5 × ULN; creatinine ≤1.5 × ULN, creatinine clearance ≥50 mL\u002Fmin; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; serum albumin ≥28 g\u002FL；thyroid stimulating hormone and free thyroxine within ±10% of normal levels; no obvious abnormality in electrocardiogram;\n8. Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;\n9. Informed consent form signed;\n10. Life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n1. Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;\n2. Other malignancy history with disease free survival \\\u003C5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;\n3. Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies\u002FmL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;\n4. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;\n5. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;\n6. Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies\u002FmL after regular antiviral therapy);\n7. Having one of the following complications: massive gastrointestinal hemorrhage, gastrointestinal perforation or obstruction; symptomatic heart diseases including unstable angina, myocardial infarction and heart failure; uncontrollable diabetes mellitus or hypertension; uncontrollable diarrhea (interfering with daily activities although receiving adequate treatment);\n8. Bleeding tendency or receiving thrombolytic or anticoagulant therapy;\n9. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;\n10. Psychiatric disorders that would interfere with cooperation with the requirements of the study;\n11. Other conditions that investigators consider not suitable for this study.","ALL","18 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)\u002F DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.",[84,85,86,87,88],"Anti-PD-1 Antibody","Radiotherapy","Rectal Cancer","MSI-H","Mmr Deficiency","2024-08-03",{"date":91,"type":92},"2024-08-06","ACTUAL",{"date":94,"type":92},"2020-08-14",{"date":96,"type":77},"2024-12",{"name":5,"class":6},1]