[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541590":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":41,"locations":24,"responsibleParty":47,"collaborators":24,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":24},{"fullName":5,"class":6},"Fujian Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"intermittent systematic chemotherapy group","EXPERIMENTAL","Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.",[13,14,15,16,17],"Drug: Gemcitabine","Drug: Cisplatin","Drug: Paclitaxel protein-bound","Drug: Capecitabine","Drug: Tislelizumab",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Gemcitabine","1000 mg\u002Fm2 on Days 1 and 8",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Cisplatin","a total of 80-100 mg\u002Fm2 for d1-3",[9],{"type":20,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Paclitaxel protein-bound","260 mg\u002Fm2 on Day 1",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Capecitabine","a dose of 1-1.25 g\u002Fm2 twice daily in in 2 weeks for one cycle",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Tislelizumab","200 mg on Day 1",[9],[42],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Shaojun Lin, DR","CONTACT","13860603879","linshaojun@yeah.net",{"type":48,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100541590","phase-2-stop-and-go-strategy-as-first-line-treatment-for-widely-metastatic-nasopharyngeal-carcinoma-100541590",false,"NCT06331845","Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma","Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial","Inclusion Criteria:\n\n1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and\u002For more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator;\n3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function;\n4. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;\n5. Able and willing to provide a signed informed consent form, and able to comply with all procedures.\n6. The time from the last chemotherapy and\u002For radiotherapy to randomization must be ≥6 months.\n\nExclusion Criteria:\n\n1. Patients with a hypersensitivity to any of the drugs used in our study;\n2. With any active autoimmune disease or history of autoimmune disease;\n3. Clinically significant cardiovascular and cerebrovascular diseases;\n4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);\n5. Active systemic infection;\n6. Drug or alcohol abuse;\n7. No or limited capacity for civil conduct;\n8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;\n9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；\n10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials.\n11. Pregnancy or breastfeeding.","ALL","18 Years","70 Years",{"count":60,"type":61},39,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).",[67,68],"Metastatic Nasopharyngeal Carcinoma","Intermittent Systematic Chemotherapy",[70,71,72],"metastatic nasopharyngeal carcinoma","systematic chemotherapy","intermittent systematic chemotherapy","NOT_YET_RECRUITING","2024-03-20",{"date":76,"type":77},"2024-03-26","ACTUAL",{"date":79,"type":61},"2024-05-01",{"date":81,"type":61},"2028-05-01",{"name":5,"class":6}]