[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622839":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":12,"centralContacts":32,"locations":12,"responsibleParty":38,"collaborators":12,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":12,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":12,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":12,"overallStatus":61,"whyStopped":12,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":12},{"fullName":5,"class":6},"Fujian Cancer Hospital","OTHER_GOV",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","NO_INTERVENTION","Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental Arm","EXPERIMENTAL","Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles.",[18],"Drug: Toripalimab",{"label":20,"type":15,"description":21,"interventionNames":22},"Exploratory Arm","Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 5 of each 21-day cycle for 3 cycles. This arm is exploratory in nature with a smaller sample size.",[18],[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DRUG","Toripalimab","Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.",[14],{"type":25,"name":26,"description":30,"armGroupLabels":31,"otherNames":12},"Toripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles.",[20],[33],{"name":34,"role":35,"phone":36,"phoneExt":12,"email":37},"Yedong Huang, MD. PhD","CONTACT","86+15959678182","drhuangyd@163.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Huang Chaobin","Professor","100622839","phase-2-timing-optimization-of-immunotherapy-during-neoadjuvant-chemotherapy-for-locally-advanced-nasopharyngeal-carcinoma-100622839",false,"NCT07388836","Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma","A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age between 18 and 70 years\n\nHistologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC\u002FUICC 8th edition stage II-III)\n\nAt least one measurable target lesion per RECIST 1.1\n\nECOG performance status of 0-1\n\nEstimated life expectancy ≥ 6 months\n\nAdequate hematologic, hepatic, renal, and coagulation function\n\nNegative pregnancy test for women of childbearing potential\n\nWillingness to use effective contraception during the study and for 12 months after treatment\n\nSigned informed consent\n\nWilling and able to comply with study procedures\n\nNot participating in any other interventional clinical trials during the study period\n\nExclusion Criteria:\n\n* re first dose\n\nActive or suspected autoimmune disease requiring systemic treatment\n\nOngoing systemic immunosuppressive therapy\n\nActive hepatitis B, hepatitis C, HIV infection, or other serious infections\n\nHistory of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer)\n\nPregnant or breastfeeding women\n\nInability or unwillingness to use contraception as required\n\nLife expectancy \\\u003C 6 months","ALL","18 Years","70 Years",{"count":53,"type":54},198,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.",[60],"Locally Advanced Nasopharyngeal Carcinoma","NOT_YET_RECRUITING","2026-01-28",{"date":64,"type":65},"2026-02-05","ACTUAL",{"date":67,"type":54},"2026-03-01",{"date":69,"type":54},"2028-05",{"name":5,"class":6}]