[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612244":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":11,"centralContacts":52,"locations":11,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,14,18,21,26,30,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU )","EXPERIMENTAL",null,[13],"Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU)","Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety run-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",[13],{"label":22,"type":23,"description":11,"interventionNames":24},"PhaseII(randomized treatment stage): physician's choice of SOC","ACTIVE_COMPARATOR",[25],"Drug: Investigator's choice of SOC",{"label":27,"type":10,"description":11,"interventionNames":28},"Phase II(randomized controlled stage): SYS6010+SG001",[29],"Drug: SYS6010+SG001",{"label":31,"type":23,"description":11,"interventionNames":32},"Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",[13],{"label":34,"type":23,"description":11,"interventionNames":35},"Phase III: physician's choice of SOC",[25],[37,44,48],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)","SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker.\n\nSG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody. Capecitabine: Capecitabine is for oral administration. 5-FU: Administration at the conventional dosage.",[9,15,19,31],[43],"SG001: Enlonstobart",{"type":38,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"Investigator's choice of SOC","1. Camrelizumab + Cisplatin + Paclitaxel\n2. Tislelizumab + Cisplatin + Paclitaxel\n3. Tislelizumab + Cisplatin + 5-FU\u002FCapecitabine",[34,22],{"type":38,"name":49,"description":50,"armGroupLabels":51,"otherNames":11},"SYS6010+SG001","SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker.\n\nSG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody.",[27],[53],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},"Clinical Trials Information Group officer","CONTACT","0311-69085587","ctr-contact@cspc.cn",{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100612244","phase-2-a-study-of-sys6010-enlonstobart-and-chemotherapy-for-first-line-treatment-of-esophageal-squamous-cell-carcinoma-100612244",false,"NCT07251062","A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.","A Phase II\u002FIII Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU\u002FCapecitabine in Subjects With First-Line Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written ICF;\n2. Age 18-75 (inclusive) years, male or female;\n3. With histologically\u002Fcytologically confirmed esophageal squamous cell carcinoma that is either locally advanced unresectable or metastatic, with no prior systemic antitumor therapy administered for the recurrent\u002Fmetastatic disease setting. Have at least one measurable lesion that meets the RECIST v 1.1 criteria at baseline;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;\n5. Life expectancy ≥ 3 months;\n\nExclusion Criteria:\n\n1. Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);\n2. Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory\u002Fco-inhibitory pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 antibodies)\n3. With a history of ≥Grade 3 allergic reactions to monoclonal antibodies, or with known hypersensitivity or intolerance to SYS6010, SG001, paclitaxel, carboplatin, cisplatin, fluorouracil, or any of their excipients;\n4. With dihydropyrimidine dehydrogenase (DPD) deficiency.","ALL","18 Years","75 Years",{"count":71,"type":72},737,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE2","PHASE3","This is a multicenter phase 2\u002F3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU\u002FCapecitabine as first-line treatment, in patients with advanced\u002Fmetastatic esophageal squamous cell carcinoma.",[79],"Esophageal Squamous Cell Carcinoma","NOT_YET_RECRUITING","2025-11-18",{"date":83,"type":84},"2025-11-26","ACTUAL",{"date":86,"type":72},"2025-12-30",{"date":88,"type":72},"2030-12-30",{"name":5,"class":6}]