[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654244":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":61,"studyPopulation":61,"armGroups":68,"interventions":84,"overallOfficials":61,"centralContacts":102,"locations":108,"responsibleParty":141,"collaborators":61,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":61,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":61,"enrollmentInfo":152,"targetDuration":61,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":61,"overallStatus":161,"whyStopped":61,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":61},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1","PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first","Up to approximately 27 months",{"measure":14,"description":15,"timeFrame":12},"Overall Survival (OS)","OS was defined as the time from randomization until the date of death from any cause",[17,20,23,26,28,30,32,34,37,40,43,46,49,52,55,58],{"measure":18,"description":19,"timeFrame":12},"Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1","ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)",{"measure":21,"description":22,"timeFrame":12},"Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1","DOR was defined as the time from CR\u002FPR to PD or death from any cause, whichever occurs first",{"measure":24,"description":25,"timeFrame":12},"Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1","DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)",{"measure":27,"description":11,"timeFrame":12},"PFS evaluated by the Investigator as per RECIST 1.1",{"measure":29,"description":19,"timeFrame":12},"ORR evaluated by the Investigator as per RECIST 1.1",{"measure":31,"description":22,"timeFrame":12},"DoR evaluated by the Investigator as per RECIST 1.1",{"measure":33,"description":25,"timeFrame":12},"DCR evaluated by the Investigator as per RECIST 1.1",{"measure":35,"description":36,"timeFrame":12},"Number and Severity of Treatment-emergent Adverse Events (TEAEs)","The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.",{"measure":38,"description":39,"timeFrame":12},"Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)","Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). All scores are transformed to a 0-100 scale. Higher scores represent better function\u002Fglobal quality-of-life status for functional and global health scales, and worse symptom burden for symptom scales.",{"measure":41,"description":42,"timeFrame":12},"Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24)","Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24). All scores are transformed to a 0-100 scale; higher scores indicate worse outcomes for symptom scales, except for sexual activity and sexual enjoyment items where higher scores indicate better outcomes.",{"measure":44,"description":45,"timeFrame":12},"Plasma Concentrations of JSKN003","Measurement of plasma concentrations of JSKN003.",{"measure":47,"description":48,"timeFrame":12},"Plasma Concentration of Total Antibody","Measurement of plasma concentration of total antibody.",{"measure":50,"description":51,"timeFrame":12},"Plasma Concentration of Free Payload","Measurement of plasma concentration of free payload.",{"measure":53,"description":54,"timeFrame":12},"Plasma Concentration of Envotumab","Measurement of plasma concentration of envotumab.",{"measure":56,"description":57,"timeFrame":12},"Incidence and Titer of Anti-Drug Antibodies","Assessment of the incidence and titer of anti-drug antibodies, as applicable.",{"measure":59,"description":60,"timeFrame":12},"Incidence and Titer of Neutralizing Antibodies","Assessment of the incidence and titer of neutralizing antibodies, as applicable.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":65,"observationalModel":61,"timePerspective":61,"maskingInfo":66},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":67,"maskingDescription":61,"whoMasked":61},"NONE",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Experimental","EXPERIMENTAL","JSKN033",[74],"Drug: JSKN033",{"label":76,"type":77,"description":78,"interventionNames":79},"Active Comparator","ACTIVE_COMPARATOR","Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.",[80,81,82,83],"Drug: Docetaxel","Drug: Topotecan","Drug: Gemcitabine (GEM)","Drug: Pemetrexed",[85,89,92,95,99],{"type":86,"name":72,"description":87,"armGroupLabels":88,"otherNames":61},"DRUG","JSKN033 should be administered subcutaneously",[70],{"type":86,"name":90,"description":90,"armGroupLabels":91,"otherNames":61},"Docetaxel",[76],{"type":86,"name":93,"description":93,"armGroupLabels":94,"otherNames":61},"Topotecan",[76],{"type":86,"name":96,"description":97,"armGroupLabels":98,"otherNames":61},"Gemcitabine (GEM)","Gemcitabine",[76],{"type":86,"name":100,"description":100,"armGroupLabels":101,"otherNames":61},"Pemetrexed",[76],[103],{"name":104,"role":105,"phone":106,"phoneExt":61,"email":107},"Xiaohua Wu, Doctor","CONTACT","086-021-64175590","wu.xh@fudan.edu.cn",[109,130],{"facility":110,"status":61,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":117,"coordinates":118},"Point",[119,120],113.25,23.11667,{"lat":120,"lon":119},[123,127],{"name":124,"role":105,"phone":125,"phoneExt":61,"email":126},"Chunyan Lan","086-020-87343468","lanchy@sysucc.org.cn",{"name":128,"role":129,"phone":61,"phoneExt":61,"email":61},"Chunyan Lan, Doctor","PRINCIPAL_INVESTIGATOR",{"facility":131,"status":61,"city":132,"state":61,"zip":61,"country":114,"countryCode":115,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Affiliated Cancer Hospital of Fudan University","Shanghai",{"type":117,"coordinates":134},[135,136],121.45806,31.22222,{"lat":136,"lon":135},[139,140],{"name":104,"role":105,"phone":106,"phoneExt":61,"email":107},{"name":104,"role":129,"phone":61,"phoneExt":61,"email":61},{"type":142,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100654244","phase-3-jskn033-versus-investigators-choice-of-chemotherapy-in-recurrent-or-metastatic-cervical-cancer-100654244",false,"NCT07797153","JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer","A Randomized, Controlled, Open-Label, Multi-center, Phase III Study of JSKN033 Versus Investigator's Choice of Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Platinum-Based Chemotherapy and PD-1\u002FL1 Inhibitor Therapy","Inclusion Criteria:\n\n* Voluntary participation and written informed consent.\n* ≥18 years;\n* ECOG performance status score of 0 or 1.\n* Expected survival of more than 3 months.\n* Histologically or cytologically confirmed recurrent or metastatic cervical cancer.\n* At least one measurable lesion in the baseline.\n* Adequate organ function.\n* Provide primary or metastatic tumor samples.\n* Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.\n\nExclusion Criteria:\n\n* Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma.\n* Other-malignancy diagnosed within 3 years prior to randomization.\n* Active central nervous system metastases.\n* Baseline imaging showing tumor invasion, compression of, or arising from vital organs.\n* Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates.\n* Inadequate washout from prior therapy before randomization.\n* Risk factors for ILD.\n* Significant cardiovascular or cerebrovascular disease.\n* Clinically-significant gastrointestinal abnormalities.\n* History of genital-tract fistula.\n* Uncontrolled pleural effusion.\n* Active or prior autoimmune-disease .\n* Uncontrolled infection.\n* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.\n* History of ≥Grade 3 immune-related adverse events irAEs.\n* Previous allogeneic bone-marrow or solid organ transplantation.\n* Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent.\n* Pregnant or lactating female participants, or women planning pregnancy during the study.\n* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.","FEMALE","18 Years",{"count":153,"type":154},368,"ESTIMATED","INTERVENTIONAL",[157],"PHASE3","This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1\u002FL1 inhibitor therapy.",[160],"Recurrent or Metastatic Cervical Cancer","NOT_YET_RECRUITING","2026-08-30",{"date":164,"type":165},"2026-09-01","ACTUAL",{"date":167,"type":154},"2026-09",{"date":169,"type":154},"2029-12",{"name":5,"class":6},2]