[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476445":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":44,"locations":54,"responsibleParty":75,"collaborators":43,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":43,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":43,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":105,"whyStopped":43,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},{"fullName":5,"class":6},"ChineseAMS","UNKNOWN",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"iTNT group","EXPERIMENTAL","The intervention of iTNT group is Short-course radiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, four cycles of PD-1 inhibitor and four cycles of CAPOX or six cycles of mFOLFOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg\u002Fm2 IV day 1，Capecitabine 1000 mg\u002Fm2 twice daily PO for 14 days(3 weeks per cycle). The regimen of PD-1 inhibitor and mFOLFOX treatment includes Sintilimab 200 mg IV day 1(3 weeks per cycle), Oxaliplatin 85 mg\u002Fm2 IV day 1, Leucovorin 400 mg\u002Fm2 IV day 1, 5-FU 400 mg\u002Fm2 IV bolus on day 1, then 1200 mg\u002Fm2\u002Fday x 2 days (total 2400 mg\u002Fm2 over 46-48 hours) IV continuous infusion(2 weeks per cycle), then followed by a total mesorectal excision(TME) or Watch \\& Wait strategy for clinical complete remission voluntary patients.",[13,14,15],"Drug: Sintilimab","Radiation: Short-course radiotherapy","Combination Product: CAPOX\u002FmFOLFOX",{"label":17,"type":18,"description":19,"interventionNames":20},"TNT group","ACTIVE_COMPARATOR","The intervention of TNT group is Short-course radiotherapy followed by neoadjuvant chemotherapy, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, four cycles of CAPOX or six cycles of mFOLFOX will be performed. The regimen of CAPOX treatment includes Oxaliplatin 130 mg\u002Fm2 IV day 1，Capecitabine 1000 mg\u002Fm2 twice daily PO for 14 days(3 weeks per cycle). The regimen of mFOLFOX treatment includes, Oxaliplatin 85 mg\u002Fm2 IV day 1, Leucovorin 400 mg\u002Fm2 IV day 1, 5-FU 400 mg\u002Fm2 IV bolus on day 1, then 1200 mg\u002Fm2\u002Fday x 2 days (total 2400 mg\u002Fm2 over 46-48 hours) IV continuous infusion(2 weeks per cycle), then followed by a total mesorectal excision(TME) or Watch \\& Wait strategy for clinical complete remission voluntary patients.",[14,15],[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Sintilimab","PD-1 inhibitor",[9],[28],"Immune checkpoint inhibitor",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"RADIATION","Short-course radiotherapy","Pelvic radiation",[17,9],[35],"hypofraction",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"COMBINATION_PRODUCT","CAPOX\u002FmFOLFOX","chemotherapy regimen",[17,9],[42],"neoadjuvant chemotherapy",null,[45,50],{"name":46,"role":47,"phone":48,"phoneExt":43,"email":49},"Yuan Tang","CONTACT","+86-15011304945","tangyuan82@126.com",{"name":51,"role":47,"phone":52,"phoneExt":43,"email":53},"Wenjue Zhang","+86-13620986880","wenjuezhang@163.com",[55,67],{"facility":56,"status":43,"city":57,"state":58,"zip":43,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":43},"Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College","Beijing","Beijing Municipality","China","CN",{"type":62,"coordinates":63},"Point",[64,65],116.39723,39.9075,{"lat":65,"lon":64},{"facility":68,"status":43,"city":69,"state":43,"zip":43,"country":59,"countryCode":60,"cosmosGeoPoint":70,"geoPoint":74,"contacts":43},"National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Shenzhen",{"type":62,"coordinates":71},[72,73],114.0683,22.54554,{"lat":73,"lon":72},{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":79,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Jing Jin, M.D.","Principal Investigator","Chinese Academy of Medical Sciences","100476445","phase-2-short-course-radiotherapy-followed-by-chemotherapy-and-pd-1-inhibitor-for-locally-advanced-rectal-cancer-100476445",false,"NCT05484024","Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer","Preoperative Short-course Radiotherapy Followed by Chemotherapy With or Without PD-1 Inhibitor for Locally Advanced Rectal Cancer: a Prospective, Multicenter, Randomized Controlled, Phase II\u002FIII Study (STELLAR II Study)","Inclusion Criteria:\n\n* Biopsy proven rectal adenocarcinoma;\n* Distance between tumour and anal verge≤ 10cm;\n* Locally advanced tumour;(8th edition AJCC\u002FUICC staging :cT3-T4N0\u002FcT2-4N+，M0) Cancer Staging must be based on pelvic MRI or Endoscopic ultrasound;\n* Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;\n* Mentally and physically fit for chemotherapy; Adequate blood counts: White blood cell count ≥3.5 x 109\u002FL Haemoglobin levels ≥100g\u002FL Platelet count ≥100 x 109\u002FL Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL)\n\n  ≤1.5× upper normal limit（UNL）\n* No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.\n* No previous pelvic radiation history；\n* Written informed consent;\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1\u002FL1 and anti-CTLA-4 or other immune experimental drugs.\n* Severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis)\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia.\n* At risk for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation.\n* history of other malignancies, excluding curable non-melanotic skin cancer and cervix carcinoma in situ；\n* Active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia.\n* Any condition investigator considered may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease.\n* Pregnancy or breast feeding\n* Immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation\n* Active hepatitis B virus (HBV) hepatitis (HBV-DNA ≥ 2000 U\u002FmL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection.\n* Oncology vaccination history or any vaccination within 4 weeks prior to the start of treatment.(Note: influenza vaccines are mostly inactivated and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed)\n* Concomitant other immune agents, chemotherapeutic agents, other drugs in clinical studies, and long term cortisol application","ALL","18 Years","75 Years",{"count":91,"type":92},588,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE2","PHASE3","This phase II\u002FIII trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma. Neoadjuvant short-course radiation therapy followed by two-drug regimen chemotherapy, such as CAPOX, were shown to be non-inferior to standard long-course chemoradiotherapy in our previous STELLAR study. Immune checkpoint inhibitors (ICIs) using monoclonal antibodies, such as PD-1 or PD-L1 inhibitor, show promising efficiency and reliable security in some limited sample prospective or retrospective studies. When treating patients with locally advanced rectal cancer, giving sequential neoadjuvant short-course radiotherapy and chemotherapy with PD-1 inhibitor may work better.",[99,100],"Rectal Neoplasms Malignant","Radiotherapy",[102,103,104,25],"rectal cancer","short-course radiotherapy","total neoadjuvant therapy","NOT_YET_RECRUITING","2022-07-29",{"date":108,"type":109},"2022-08-02","ACTUAL",{"date":111,"type":92},"2022-08-06",{"date":113,"type":92},"2030-07-31",{"name":79,"class":115},"OTHER",2]