[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653828":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":44,"studyPopulation":11,"armGroups":45,"interventions":56,"overallOfficials":11,"centralContacts":66,"locations":72,"responsibleParty":92,"collaborators":11,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":11,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":11,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":110,"conditions":111,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Taizhou Mabtech Pharmaceutical Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Overall Survival (Phase 3)",null,"Up to 2 years.",{"measure":14,"description":11,"timeFrame":12},"Objective Response Rate (Phase 2)",[16,19,21,23,26,28,30],{"measure":17,"description":18,"timeFrame":12},"Duration of response","The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively in Phase 3.",{"measure":20,"description":18,"timeFrame":12},"Disease control rate",{"measure":22,"description":18,"timeFrame":12},"Progression-Free Survival",{"measure":24,"description":25,"timeFrame":12},"Objective Response Rate (Phase 3)","The Blinded Independent Imaging Review Committee (BIRC) and Investigators will evaluated，respectively.",{"measure":27,"description":11,"timeFrame":12},"Overall Survival (Phase 2)",{"measure":29,"description":18,"timeFrame":12},"Time to Progression",{"measure":31,"description":32,"timeFrame":33},"Number of participants with treatment-related adverse events as assessed by CTCAE v6.0","Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE V6.0.\n\nIncidence of AE leading to dose interruption, dose delay and treatment discontinuation.","From the date of informed consent signature until 28 days after the last dose (each cycle is 21 days, up to 35 cycles or 2 years).",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":11,"whoMasked":40},"TRIPLE",[41,42,43],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a Phase II\u002FIII clinical trial, aimed to evaluate the efficacy and safety of Enlituo® combined with Anyouping® plus platinum and nab-paclitaxel chemotherapy as first-line therapy for advanced, recurrent or metastatic HNSCC.\n\nPhase II Part Approximately 60 participants will be enrolled and randomly assigned at a 1:1 ratio to the experimental group.\n\nPhase III Part Approximately 302 participants will be enrolled and randomly assigned in a 1:1 double-blind manner to the experimental group.",[46,51],{"label":47,"type":48,"description":11,"interventionNames":49},"Enlituo®","EXPERIMENTAL",[50],"Drug: Enlituo® + Anyouping® + PBC",{"label":52,"type":53,"description":11,"interventionNames":54},"Placebo","PLACEBO_COMPARATOR",[55],"Drug: Placebo-Enlituo + Anyouping® + PBC",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","Enlituo® + Anyouping® + PBC","Enlituo®：Enlituo® is administered according to the protocol. Anyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.",[47],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"Placebo-Enlituo + Anyouping® + PBC","Comparator in Phase 2 is Anyouping® + PBC. Comparator in Phase 3 is Placebo-Enlituo + Anyouping® + PBC. Placebo-Enlituo (only in Phase 3)：Placebo-Enlituo is administered according to the protocol.\n\nAnyouping®：Anyouping® is administered according to the protocol. Platinum-based chemotherapy (PBC)：Cisplatin (DDP) or Carboplatin (CBP) plus Albumin-bound Paclitaxel (nab-paclitaxel) are administered according to the protocol.",[52],[67],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"Zheng Zhang","CONTACT","+86 25-85566666","zhangzheng1@zaiming.com",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200120","China","CN",{"type":82,"coordinates":83},"Point",[84,85],121.45806,31.22222,{"lat":85,"lon":84},[88],{"name":89,"role":69,"phone":90,"phoneExt":11,"email":91},"Ye Guo","+86 21-38804518","pattrickguo@gmaiI.com",{"type":93,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653828","phase-2-a-clinical-trial-comparing-the-efficacy-and-safety-of-anyouping-and-platinum-based-chemotherapy-with-or-without-enlituo-in-advanced-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-100653828",false,"NCT07791745","A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With or Without Enlituo® in Advanced Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma.","A Prospective, Multicenter, Randomized, Controlled Phase II\u002FIII Study to Evaluate the Efficacy and Safety of Enlituo® Plus Anyouping® and Platinum-Based Chemotherapy Versus Anyouping® Plus Platinum-Based Chemotherapy as First-Line Treatment for Advanced, Recurrent or Metastatic of the Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol;\n* Aged ≥ 18 years;\n* Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy;\n* Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant\u002Fadjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant\u002Fadjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1\u002FPD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded.\n\n(Remark: Subjects previously treated with PD-1\u002FPD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.)\n\n* Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment;\n* For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment.\n\nExclusion Criteria:\n\n* Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin;\n* Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ of the cervix and\u002For breast cancer treated with curative resection;\n* Participants with an expected survival of less than 6 months and\u002For rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment);\n* Participants eligible for curative-intent local therapy;\n* Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose);\n* Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements;\n* Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.","ALL","18 Years",{"count":104,"type":105},362,"ESTIMATED","INTERVENTIONAL",[108,109],"PHASE2","PHASE3","A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma.",[112],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","2026-09-30",{"date":115,"type":116},"2026-10-05","ACTUAL",{"date":118,"type":116},"2026-09-16",{"date":120,"type":105},"2032-08-30",{"name":5,"class":6},1]