[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603628":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":21,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":21,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":21,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EBV Lytic Reactivation Therapy","EXPERIMENTAL","Patients will receive 4 to 6 cycles of gemcitabine, cisplatin, and PD-1 antibody, with oral administration of valganciclovir hydrochloride tablets during the first 3 cycles. Following completion of 4 to 6 cycles, patients will continue with maintenance therapy using PD-1 antibody.",[13,14],"Drug: Valganciclovir Hydrochloride Tablets","Drug: gemcitabine, cisplatin, and PD-1 antibody",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Valganciclovir Hydrochloride Tablets","Valganciclovir hydrochloride tablets will be administered at 900 mg twice daily from day 1 to day 14, followed by 450 mg twice daily from day 15 to day 20, for a total of 3 cycles.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"gemcitabine, cisplatin, and PD-1 antibody","Gemcitabine 1000 mg\u002Fm² will be administered intravenously on days 1 and 8; cisplatin 80 mg\u002Fm² intravenously on day 1; and PD-1 antibody intravenously on day 1. Each cycle is 21 days in duration, and treatment will be administered for a total of 4 to 6 cycles.\n\nFollowing completion of the 4 to 6 cycles, patients will continue PD-1 antibody maintenance therapy (every 3 weeks) for up to two years or until disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of informed consent, or death.",[9],[27],{"name":28,"affiliation":29,"role":30},"Hai-Qiang Mai, MD,PhD","Sun Yat-sen Universitty Cancer Center","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Qiu-Yan Chen, MD,PhD","CONTACT","86-20-87343380","chenqy@sysucc.org.cn",[38],{"facility":29,"status":21,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Guangzhou","Guangdong","510060","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":28,"role":34,"phone":52,"phoneExt":21,"email":53},"+862087343643","maihq@sysucc.org.cn",{"type":30,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":57,"oldNameTitle":21,"oldOrganization":21},"Hai-Qiang Mai,MD,PhD","Professor","Sun Yat-Sen University Cancer Center","100603628","phase-2-ebv-lytic-reactivation-therapy-combined-with-pd-1-antibody-in-recurrentmetastatic-nasopharyngeal-carcinoma-100603628",false,"NCT07138989","EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial","Inclusion Criteria:\n\n* Patients must voluntarily participate and provide written informed consent.\n* Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.\n* Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.\n* Age ≥ 18 years and ≤ 75 years, of any sex.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival time ≥ 3 months.\n* Baseline plasma EBV DNA \\> 0 copies\u002FmL.\n* Adequate organ function confirmed by the following criteria (no blood component transfusions or use of hematopoietic growth factors within 2 weeks prior to study treatment initiation):\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 100 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin . Total bilirubin (TBil) ≤ 1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN; AST and ALT ≤ 5 × ULN). Serum albumin ≥ 28 g\u002FL.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitors.\n* Receipt of radiotherapy, biological therapy (e.g., tumor vaccines, cytokines, or growth factors), or other immunotherapy (excluding PD-1 and PD-L1 inhibitors), or any other anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of study drug, whichever is shorter.\n* Prior treatment targeting Epstein-Barr virus (EBV) specifically.\n* History of any Grade ≥3 bleeding event, as defined by CTCAE v5.0, within 4 weeks prior to screening, or patients deemed at high risk of bleeding by the investigator.\n* Presence of necrotic lesions within 4 weeks prior to screening, with high risk of major hemorrhage as judged by the investigator.\n* Known congenital or acquired immunodeficiency (e.g., HIV-positive individuals).\n* Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to initiation of study treatment.\n* History of active tuberculosis (TB). Suspected active TB must be excluded through chest X-ray, sputum examination, and clinical assessment of signs and symptoms.\n* Patients with HBV DNA ≥1000 copies\u002FmL. Patients with positive hepatitis C antibody results may only be enrolled if polymerase chain reaction (PCR) testing confirms HCV RNA negativity.\n* Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.\n* History of other malignancies, except for adequately treated basal cell carcinoma or carcinoma in situ of the cervix.\n* Uncontrolled cardiovascular conditions, including but not limited to: Heart failure with NYHA classification ≥2; Unstable angina; Myocardial infarction within the past year; Supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function.\n* Severe and uncontrolled medical illnesses or infections.\n* Concurrent participation in another clinical trial or use of another investigational agent.\n* Refusal or inability to sign informed consent.\n* Any other contraindications to study treatment as determined by the investigator.\n* Individuals with personality disorders or psychiatric conditions, and those lacking or having limited legal capacity to provide consent.","ALL","18 Years","75 Years",{"count":69,"type":70},10,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent\u002Fmetastatic NPC (r\u002Fm NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r\u002Fm EBV-positive NPC.",[76],"Nasopharyngeal Cancinoma (NPC)",[78,79,80],"nasopharyngeal carcinoma","Epstein-Barr virus","immunotherapy","NOT_YET_RECRUITING","2025-08-16",{"date":84,"type":85},"2025-08-24","ACTUAL",{"date":87,"type":70},"2025-08-19",{"date":89,"type":70},"2031-08-18",{"name":5,"class":6},1]