[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607440":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":61,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":26,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy","EXPERIMENTAL","Immunotherapy: Patients received maintenance treatment with PD-1 monoclonal antibody (a 3-week course as one cycle) until disease progression or reach 2 years.\n\nChemotherapy: Platinum-containing doublet chemotherapy (before enrollment, 4-6 cycles) and concurrent cisplatin during radiotherapy.\n\nRadiotherapy: Patients received intensity-modulated radiotherapy technology. Experimental group: GTVnx: 69.96 Gy\u002F33 Fr\u002F2.12 Gy; GTVnd: 69.96 Gy\u002F33 Fr\u002F2.12 Gy; CTV1: 60.60 Gy\u002F33 Fr\u002F1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).",[13],"Radiation: Reduced-Target Radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Full-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy","ACTIVE_COMPARATOR","Immunotherapy: Patients received maintenance treatment with PD-1 monoclonal antibody (a 3-week course as one cycle) until disease progression or reach 2 years.\n\nChemotherapy: Platinum-containing doublet chemotherapy (before enrollment, 4-6 cycles) and concurrent cisplatin during radiotherapy.\n\nRadiotherapy: Patients received intensity-modulated radiotherapy technology. Control group: GTVnx: 69.96 Gy\u002F33 F\u002F2.12 Gy; GTVnd: 69.96 Gy\u002F33 F\u002F2.12 Gy; CTV1: 59.4 Gy\u002F33 F\u002F1.8 Gy; CTV2: 54 Gy\u002F33 F\u002F1.64 Gy.",[19],"Radiation: Conventional Full-Target Radiotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Reduced-Target Radiotherapy","Experimental group: GTVnx: 69.96 Gy\u002F33 Fr\u002F2.12 Gy; GTVnd: 69.96 Gy\u002F33 Fr\u002F2.12 Gy; CTV1: 60.60 Gy\u002F33 Fr\u002F1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Full-Target Radiotherapy","Control group: GTVnx: 69.96 Gy\u002F33 F\u002F2.12 Gy; GTVnd: 69.96 Gy\u002F33 F\u002F2.12 Gy; CTV1: 59.4 Gy\u002F33 F\u002F1.8 Gy; CTV2: 54 Gy\u002F33 F\u002F1.64 Gy.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ming-Yuan Chen, MD,PhD","CONTACT","86-13903052650","chmingy@mail.sysu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Rui You, MD, PhD","13580439820","your5@mail.sysu.edu.cn",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting","RECRUITING","Zhuhai","China","CN",{"type":49,"coordinates":50},"Point",[51,52],113.56778,22.27694,{"lat":52,"lon":51},[55],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":56},"chmingy@email.sysu.edu.cn",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ming-Yuan Chen","Professior",[62,64,66,69,72,74,76,78,80,82,84,86,88,90,92],{"name":63,"class":6},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":65,"class":6},"Cancer Hospital of Guangxi Medical University",{"name":67,"class":68},"Fujian Cancer Hospital","OTHER_GOV",{"name":70,"class":71},"The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University","UNKNOWN",{"name":73,"class":6},"Sun Yat-Sen University Cancer Center",{"name":75,"class":6},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University",{"name":77,"class":6},"Zhejiang Cancer Hospital",{"name":79,"class":6},"West China Hospital",{"name":81,"class":6},"Xiangya Hospital of Central South University",{"name":83,"class":6},"Affiliated Cancer Hospital of Shantou University Medical College",{"name":85,"class":6},"Yunnan Cancer Hospital",{"name":87,"class":6},"First Affiliated Hospital of Kunming Medical University",{"name":89,"class":6},"Wuzhou Red Cross Hospital",{"name":91,"class":6},"Zhongshan People's Hospital, Guangdong, China",{"name":93,"class":6},"Southern Medical University, China","100607440","phase-3-phase-iii-non-inferiority-trial-reduced-target-vs-full-target-imrt-after-chemo-in-immunotherapy-treated-metastatic-nasopharyngeal-cancer-100607440",false,"NCT07188584","Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer","A Multicenter, Phase III Non-Inferiority Clinical Trial: Locoregional Volume-Reduction Versus Conventional Definitive Target IMRT Following Full-Dose Chemotherapy for Treatment-Naïve Distant Metastatic Nasopharyngeal Carcinoma Undergoing Full-Course Immunotherapy","Inclusion Criteria:\n\n* Age: 18 years - 70 years.\n* The patient has signed the informed consent form and is willing and able to follow the visit schedule, treatment plan, laboratory tests and other research procedures as per the research plan.\n* Newly diagnosed distant metastasis patients who achieved complete response (CR) or partial response (PR) after receiving adequate first-line systematic therapy (platinum-containing doublet chemotherapy + PD-1 monoclonal antibody).\n* Nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III), confirmed by histological and\u002For cytological examination, with metastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory).\n* Clinical stage: TanyNanyM1, stage IVB (AJCC 9th edition).\n* ECOG score: 0-1.\n* Female subjects with reproductive capacity must have a negative urine or serum pregnancy test within 7 days prior to enrollment, and must agree to take effective contraceptive measures during the study.\n* For male subjects, if the female partner still has reproductive capacity, the male subject must agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* Patients with malignant pleural effusion or those with other malignant tumors\n* Patients who have received ≥2 prior lines of systemic therapy.\n* Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.\n* Patients with grade ≥ II coronary heart disease, arrhythmia (including QTc interval prolongation in males \\> 450 ms, females \\> 470 ms) and heart failure.\n* Patients who received systemic or local glucocorticoid treatment within 4 weeks prior to enrollment.\n* Patients with comorbidities requiring long-term use of immunosuppressive drugs or requiring systemic or local use of corticosteroids at immunosuppressive doses.\n* Patients with active pulmonary tuberculosis (TB), who are undergoing anti-TB treatment or have received anti-TB treatment within 1 year prior to screening.\n* HIV-positive individuals; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps\u002Fml); chronic hepatitis C blood screening positive (HCV antibody positive).\n* Patients who received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.\n* At the time of randomization, the expected lifespan of the patients was less than 6 months.\n* Other patients deemed unsuitable for inclusion by the treating physicians.","ALL","18 Years","70 Years",{"count":105,"type":106},166,"ESTIMATED","INTERVENTIONAL",[109],"PHASE3","In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with\u002Fwithout CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of \"immunotherapy combined with reduced-target radiotherapy\" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.",[112],"Nasopharyngeal Carcinoma (NPC)",[114,115,23,116],"Distant Metastasis Nasopharyngeal Carcinoma","Full Course Immunotherapy","Full-dose Chemotherapy","2025-12-02",{"date":119,"type":120},"2025-12-09","ACTUAL",{"date":122,"type":120},"2025-08-20",{"date":124,"type":106},"2031-07-01",{"name":59,"class":6},1]