[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604548":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":85,"collaborators":11,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fudan University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Long-course Radiotherapy plus chemotherapy group","EXPERIMENTAL",null,[13,14,15,16,17],"Radiation: Long-course radiotherapy","Drug: Oxaliplatin","Drug: Capecitabine","Drug: Celecoxib","Drug: Serplulimab",{"label":19,"type":10,"description":11,"interventionNames":20},"Short-course Radiotherapy plus immunochemotherapy group",[14,15,16,21,17],"Radiation: Short-course radiotherapy",[23,30,35,39,43,49],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Long-course radiotherapy","Long-course radiation: 50Gy\u002F25Fx",[9],[29],"LCRT",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","Oxaliplatin","Oxaliplatin: 130mg\u002Fm2 d1 q3w",[9,19],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Capecitabine","Xeloda",[9,19],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Celecoxib","celecoxib 200 mg orally twice a day",[9,19],{"type":24,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Short-course radiotherapy","Short-course radiotherapy: 25Gy\u002F5Fx",[19],[48],"SCRT",{"type":31,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"Serplulimab","Serplulimab 300mg, d1, q3w",[9,19],[54],{"name":55,"affiliation":5,"role":56},"Zhen Zhang, M.D, PH.D","PRINCIPAL_INVESTIGATOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":11,"email":61},"CONTACT","18801735029","zhen_zhang@fudan.edu.cn",{"name":63,"role":59,"phone":64,"phoneExt":11,"email":65},"Yajie Chen, PH.D","18917239680","16111230008@fudan.edu.cn",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200030","China","CN",{"type":76,"coordinates":77},"Point",[78,79],121.45806,31.22222,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":11,"email":61},"Zhang Zhen, MD PhD","+86 18017312217",{"type":56,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Zhen Zhang","Professor","100604548","phase-2-long-course-chemoradiotherapy-or-short-course-radiotherapy-combined-with-capox-pd-1antibody-and-cox-2-inhibitor-for-mss-locally-advanced-rectal-cancer-serrac-100604548",false,"NCT07150949","Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)","A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)","Inclusion Criteria:\n\n1. Age 18-75 years, gender not limited\n2. Pathologically confirmed rectal adenocarcinoma\n3. ≤10 cm from the anus\n4. Baseline stage T3-4\u002FN+\n5. No distant metastasis\n6. MSI\u002FMMR status MSS\u002FpMMR\n7. Karnofsky performance status score ≥70\n8. No prior chemotherapy or other anti-cancer treatment prior to enrollment\n9. No prior immunotherapy prior to enrollment\n10. Ability to comply with the study protocol\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;\n4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n7. Uncontrolled infection which needs systemic therapy;\n8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection\n10. Allergic to any component of the therapy.","ALL","18 Years","75 Years",{"count":99,"type":100},138,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4\u002FN+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy\u002F25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy\u002F5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.",[106,107],"Locally Advanced Rectal Cancer","Neoadjuvant Therapy","2025-08-27",{"date":110,"type":111},"2025-09-02","ACTUAL",{"date":113,"type":100},"2025-08-28",{"date":115,"type":100},"2028-08-31",{"name":5,"class":6},1]