[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540929":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":79,"collaborators":25,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":25,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT+LDRT+PD-1+Chemotherapy","EXPERIMENTAL","Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.",[13,14,15,16,17,18],"Radiation: SBRT","Radiation: Low-dose Radiotherapy (LDRT)","Drug: Toripalimab","Drug: Gemcitabine","Drug: Cisplatin","Radiation: IMRT",[20,26,30,35,39,42],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","SBRT","SBRT for metastatic lesions",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Low-dose Radiotherapy (LDRT)","LDRT for metastatic lesions",[9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"DRUG","Toripalimab","6 cycles for combined therapy. Toripalimab maintenance for 1 year.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":25},"Gemcitabine","6 cycles for combined therapy.",[9],{"type":31,"name":40,"description":37,"armGroupLabels":41,"otherNames":25},"Cisplatin",[9],{"type":21,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"IMRT","IMRT for primary lesion",[9],[47],{"name":48,"affiliation":5,"role":49},"Chong Zhao, MD. PhD.","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":25,"email":55},"Jingjing Miao, MD.","CONTACT","13631355201","miaojj@sysucc.org.cn",{"name":48,"role":53,"phone":57,"phoneExt":25,"email":58},"+8687342638","zhaochong@sysucc.org.cn",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":25,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":68,"coordinates":69},"Point",[70,71],113.25,23.11667,{"lat":71,"lon":70},[74,77],{"name":75,"role":53,"phone":76,"phoneExt":25,"email":58},"Chong Zhao, M.D","02087342638",{"name":78,"role":53,"phone":54,"phoneExt":25,"email":55},"Jingjing Miao, M.D.",{"type":49,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Zhao Chong","Dr. Prof.","100540929","phase-2-sbrt-and-ldrt-combined-with-pd-1-antibody-and-chemotherapy-in-rm-nasopharyngeal-carcinoma-100540929",false,"NCT06323239","SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r\u002Fm Nasopharyngeal Carcinoma","Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial","Inclusion Criteria:\n\n* Diagnosed as recurrence\u002Fmetastatic NPC\n* Histopathological diagnosis of NPC(WHO II\u002FIII)\n* ECOG 0-1 point\n* No treatment to r\u002FmNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;\n* No contraindications to immunotherapy and chemoradiotherapy;\n* At least one lesion could receive SBRT safely;\n* Subject must have a measurable target lesion based on RECIST v1.1;\n* Adequate marrow function: WBC count ≥ 3×10E9\u002FL, NE count ≥ 1.5×10E9\u002F L, HGB ≥ 90g\u002FL, PLT count ≥ 100×10E9\u002FL;\n* Adequate liver function: ALT\u002FAST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;\n* Adequate renal function: BUN\u002FCRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml\u002Fmin (Cockcroft-Gault formula);\n* Take effective contraceptions during and three months after treatment;\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;\n* Unexplained fever \\> 38.5 #, except for tumor fever;\n* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);\n* Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers\u002Fml) or hepatitis C virus (HCV) antibody positive;\n* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy;\n* Pregnant or breastfeeding;\n* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;\n* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;\n* Any other condition, including mental illness or domestic\u002Fsocial factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.","ALL","18 Years","75 Years",{"count":93,"type":94},148,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent\u002Fmetastatic nasopharyngeal carcinoma patients.",[100],"Nasopharyngeal Carcinoma",[22,102,103,104],"Low-dose radiotherapy","PD-1 antibody","Chemotherapy","2026-05-06",{"date":107,"type":108},"2026-05-11","ACTUAL",{"date":110,"type":108},"2024-07-15",{"date":112,"type":94},"2028-12",{"name":5,"class":6},1]