[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555201":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":35,"responsibleParty":50,"collaborators":32,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":32,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":32,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":38,"whyStopped":32,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimotuzumab combine with TGP","EXPERIMENTAL","Base on TGP(Toripalimab, Gemcitabine, and Cisplatin) regimen, the patients will receive Nimotuzamab treatment.",[13],"Drug: Nimotuzumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nimotuzumab","nimotuzumab, toripalimab, gemcitabine, cisplatin",[9],[21],"no other invention names",[23],{"name":24,"affiliation":25,"role":26},"He Xiaohui","Department of Medical Oncology","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Yang Sheng","CONTACT","86-10-87788507",null,"medart@126.com",{"name":24,"role":30,"phone":32,"phoneExt":32,"email":32},[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":32},"National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medcial Science and Peking Union Medical College","RECRUITING","Beijing","Beijing Municipality","1000000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},{"type":51,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100555201","phase-2-nimotuzumab-combined-with-tgp-as-first-line-therapy-in-patients-with-recurrentmetastatic-nasopharyngeal-carcinoma-100555201",false,"NCT06509009","Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","Nimotuzumab Combined With Toripalimab\u002FGemcitabine\u002FCisplatin as First-line Therapy in Patients With Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\nSigned written informed consent form.\n\nAge between 18 and 75 years, inclusive, without gender restriction.\n\nHistologically confirmed diagnosis of recurrent\u002Fdistant metastasis nasopharyngeal carcinoma, first line patients and unsuitable for local operation treatment.\n\nEGFR expression positive.\n\nPresence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.\n\nECOG Performance Status (PS) score of 0 or 2.\n\nExpected survival duration of at least 3 months.\n\nWhite blood cell count ≥ 3 × 10\\^9\u002FL; absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 100 × 10\\^9\u002FL; hemoglobin level ≥ 90 g\u002FL.\n\nSerum creatinine level ≤ 1.2 mmol\u002FL or creatinine clearance ≥ 60 ml\u002Fmin.\n\nSerum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in case of liver metastasis, ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (in case of liver metastasis, ≤ 5.0 × ULN).\n\nFemale patients must have a negative urine pregnancy test prior to study enrollment (this criterion does not apply to patients with bilateral ovarian resection and\u002For hysterectomy or postmenopausal patients).\n\n\\-\n\nExclusion Criteria:\n\nSubjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.\n\nSubjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.\n\nPatients with severe underlying diseases that preclude tolerance to the treatment.\n\nHistory of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.\n\nPresence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, etc.\n\nSubjects with contraindications to immunotherapy, including those with immune dysfunction diseases (such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, HIV infection, hepatitis B, hepatitis C, chronic use of steroids for autoimmune diseases), recipients of allogeneic transplants, patients with interstitial lung disease, or those with meningeal metastasis or progressive brain metastasis.\n\nAllergy to any of the drugs or their components used in the study protocol. Grade 2 or higher peripheral neuropathy or hearing loss according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.\n\nPregnant women (confirmed by blood or urine human chorionic gonadotropin \\[HCG\\] test) or lactating mothers, or subjects of reproductive age who are unwilling or unable to adopt effective contraceptive measures until at least 6 months after the last treatment in the study.\n\n\\-","ALL","18 Years","75 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine\u002Fcisplatin regimen treatment recurrent\u002Fdistant-metastasis nasopharyngeal carcinoma.",[70],"Nasopharyngeal Carcinoma by AJCC V8 Stage",[72],"nasopharyngeal carcinoma","2025-09-16",{"date":75,"type":76},"2025-09-19","ACTUAL",{"date":78,"type":76},"2024-08-30",{"date":80,"type":64},"2027-05-30",{"name":5,"class":6},1]