[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-nasopharynx-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-nasopharynx-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100577787","phase-1-egfr-antibody-combined-with-pd-1-inhibitor-and-chemotherapy-in-rm-nasopharyngeal-carcinoma-100577787",false,"NCT06802835","EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R\u002FM Nasopharyngeal Carcinoma","EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I\u002FII Clinical Trial","Inclusion Criteria:\n\n* Patients with nasopharyngeal carcinoma who have recurred\u002Fmetastasized after initial treatment or radical treatment;\n* Age 18-75, male or female;\n* Pathological diagnosis of nasopharyngeal carcinoma;\n* ECOG score 0-1;\n* Have not previously received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biotherapy for recurrence\u002Fmetastasis;\n* No contraindications of chemotherapy, immunotherapy and targeted therapy;\n* At least 1 measurable lesion that meets RECIST 1.1 criteria;\n* Blood routine examination standards should meet: WBC≥3.0×109\u002FL, ANC≥1.5×109\u002FL, PLT≥100×109\u002FL, HGB≥90g\u002FL (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct);\n* Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml\u002Fmin (Cockcroft-Gault formula);\n* Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use;\n* The myocardial enzyme spectra were in the normal range;\n* Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an effective method of contraception during the trial and for 3 months after the last anti-PD-1 antibody administration. For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and within 3 months after the last anti-PD-1 antibody administration;\n* The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;\n\nExclusion Criteria:\n\n* Patients with recurrence who can be treated with local resection or radiotherapy;\n* Known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;\n* Patients have symptoms of central nervous system metastasis such as brain edema and need hormonal intervention;\n* Had an active infection or unexplained fever \\>38.5℃ during screening or prior to the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled);\n* Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be included after normal hormone replacement therapy\\]); Patients with vitiligo or complete remission of asthma in childhood without any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included;\n* Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B (HBV-DNA≥103 copy number \u002Fml), or hepatitis C (hepatitis C antibody positive and HCR-RNA above the lower detection limit of analytical methods);\n* Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;\n* Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) \\\u003C50% indicated by cardiac color ultrasound; Myocardial infarction within 1 year;\n* If the subject has undergone major surgery, the toxic effects and\u002For complications of the surgical intervention must be fully recovered before treatment is initiated;\n* Within 4 weeks prior to the first use of the investigational drug (participants in the follow-up period are counted as the last use of the investigational drug or device) or are currently participating in another clinical study;\n* Live vaccine received within 4 weeks prior to the first administration of the investigational drug is allowed to receive inactivated virus vaccine for seasonal influenza by injection, but not live attenuated influenza vaccine for nasal administration;\n* Pregnant or lactating women;\n* In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.","ALL","18 Years","75 Years",{"count":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","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 EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent\u002Fmetastatic nasopharyngeal carcinoma patients.",[28,29,30],"Nasopharyngeal Cancinoma (NPC)","Recurrent Nasopharynx Carcinoma","Metastatic Nasopharyngeal Carcinoma",[32,33,34],"EGFR antibody","PD-1 antibody","chemotherapy","RECRUITING","2026-05-06",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":39},"2025-07-09",{"date":43,"type":21},"2029-06",{"name":45,"class":46},"Sun Yat-sen University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100618486","phase-2-pd-1-inhibitor-plus-chemotherapy-followed-by-immediate-versus-selective-re-irradiation-for-locally-advanced-recurrent-npc-100618486","NCT07332247","PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC","An Open-Label, Randomized Controlled Phase II Clinical Trial of PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Age 18-70 years, any gender.\n2. Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.\n3. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).\n4. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.\n5. ECOG performance status 0-1.\n6. Expected survival ≥ 3 months.\n7. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma\n8. No contraindications to immunotherapy, chemotherapy, or re-irradiation.\n9. Adequate organ function within 14 days before first dose, defined as:\n\n   Hematology：Hemoglobin ≥ 90 g\u002FL，ANC ≥ 1.5 × 10⁹\u002FL，Platelet count ≥ 100 × 10⁹\u002FL Renal Function：Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) \u002F eGFR ≥ 60 mL\u002Fmin Liver Function：Total bilirubin ≤ 1.5 × ULN，AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases\n10. INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range，APTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range.\n\nExclusion Criteria:\n\n1. Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence\n2. Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.\n3. Prior treatment with PD-1\u002FPD-L1 or CTLA-4 inhibitors.\n4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.\n5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma\u002Fatopy.\n6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.\n7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies\u002FmL\n8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative\n9. HIV infection\n10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).\n11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.\n12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound.\n13. Pregnant or breastfeeding women, or those planning pregnancy during the study period.\n14. Known allergy or hypersensitivity to study drugs or their excipients.\n15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.","70 Years",{"count":57,"type":21},94,[25],"This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.",[61,29],"Nasopharangeal Cancer",[63],"Locally Advanced Recurrent Nasopharyngeal Carcinoma","2026-02-02",{"date":66,"type":39},"2026-02-04",{"date":68,"type":21},"2026-02-03",{"date":70,"type":21},"2035-02-03",{"name":45,"class":46}]