[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653656":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":50,"overallOfficials":32,"centralContacts":58,"locations":68,"responsibleParty":86,"collaborators":32,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":32,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":32,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":32,"overallStatus":107,"whyStopped":32,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Survival","Measure description: Defined as time from randomization until the date of death due to any cause","Until death, assessed up to approximately 2 years",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Progression-free survival (PFS) by investigator assessment","Measure description: Defined as time from randomization until progression or death as assessed by the investigator","Until progression or death, assessed up to approximately 1 year",{"measure":19,"description":20,"timeFrame":21},"Objective response rate (ORR) by investigator assessment","Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator","Until progression, assessed up to approximately 1 year",{"measure":23,"description":24,"timeFrame":17},"Duration of response (DOR) by investigator assessment","Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator",{"measure":26,"description":27,"timeFrame":21},"Disease control rate (DCR) by investigator assessment","Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator",{"measure":29,"description":30,"timeFrame":31},"Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs)","Measure description: Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0","until to 30 days after the last dose，assessed up to approximately 2 years",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,45],{"label":41,"type":42,"description":32,"interventionNames":43},"Treatment group A: FH-006","EXPERIMENTAL",[44],"Drug: FH-006",{"label":46,"type":47,"description":32,"interventionNames":48},"Treatment group B: Paclitaxel, Docetaxel, Irinotecan.","ACTIVE_COMPARATOR",[49],"Drug: Paclitaxel, Docetaxel, Irinotecan",[51,55],{"type":52,"name":53,"description":53,"armGroupLabels":54,"otherNames":32},"DRUG","FH-006",[41],{"type":52,"name":56,"description":56,"armGroupLabels":57,"otherNames":32},"Paclitaxel, Docetaxel, Irinotecan",[46],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},"Shilong Yu","CONTACT","+86-021-23511999","lin.ma.lm60@hengrui.com",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":67},"Liang Hu","18036618148","Liang.hu@hengrui.com",[69],{"facility":70,"status":32,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Shandong Provincial Cancer Hospital","Jinan","Shandong","250117","China","CN",{"type":77,"coordinates":78},"Point",[79,80],116.99722,36.66833,{"lat":80,"lon":79},[83],{"name":84,"role":85,"phone":32,"phoneExt":32,"email":32},"Jinming Yu","PRINCIPAL_INVESTIGATOR",{"type":87,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100653656","phase-3-fh-006-versus-investigators-choice-of-chemotherapy-in-patients-with-locally-advanced-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-who-have-failed-prior-pd-1pd-l1-inhibitor-combined-with-platinum-based-chemotherapy-100653656",false,"NCT07790380","FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1\u002FPD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.","A Randomized, Open-label, Multicenter, Phase III Study of FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1\u002FPD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.","Inclusion Criteria:\n\n1. Age 18 to 75 years old (including boundary values)\n2. Volunteer to participate in this clinical study and sign informed consent;\n3. ECOG score 0-1;\n4. Expected survival ≥3 months;\n5. Patients diagnosed with esophageal squamous cell carcinoma by histological or cytological examination;\n6. Previously, only PD-1\u002FPD-L1 Inhibitor Combined With Platinum-Based Chemotherapy were received;\n7. There is at least one measurable lesion that meets the RECIST 1.1 criteria;\n8. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study\n2. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 6.0 Grade≤1;\n3. Individuals with Leptomeningeal metastasis or Active brain metastases;\n4. Individuals with a history of GI perforation or fistula, unstable GI bleeding;\n5. Individuals with a history of severe cardiovascular and cerebrovascular diseases;\n6. The researcher determined that there are other situations that are not suitable for participation.","ALL","18 Years","75 Years",{"count":99,"type":100},480,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","The study compares the overall survival (OS) of FH-006 and the second-line chemotherapy selected by the investigators for treating esophageal squamous cell carcinoma patients.",[106],"Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1\u002FPD-L1 Inhibitors Combined With Platinum-based Chemotherapy","NOT_YET_RECRUITING","2026-08-25",{"date":110,"type":111},"2026-08-27","ACTUAL",{"date":113,"type":100},"2026-10-10",{"date":115,"type":100},"2029-06-30",{"name":5,"class":6},1]