[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529185":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JS004 plus Toripalimab","EXPERIMENTAL","JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years",[13],"Biological: JS004 in combination with Toripalimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Investigator-Selected Chemotherapy","ACTIVE_COMPARATOR","Bendamustine or gemcitabine",[19],"Drug: Bendamustine or gemcitabine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","JS004 in combination with Toripalimab","Participants will receive JS004 in combination with Toripalimab (200 mg\u002F240 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.",[9],null,{"type":28,"name":17,"description":29,"armGroupLabels":30,"otherNames":26},"DRUG","Participants will receive Investigator-Selected chemotherapy of EITHER bendamustine by IV infusion at a dose of 90 or 120 mg\u002Fm\\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose of 1000 mg\u002Fm\\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yuqin Song, Ph.D","CONTACT","010-88196118","SongYQ_VIP@163.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Jun Huang","010-88196023","gcp_xy01@bjcancer.org",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100529185","phase-3-a-phase-iii-clinical-study-comparing-js004-plus-toripalimab-with-investigator-selected-chemotherapy-in-patients-with-pd-l1monoclonal-antibody-refractory-classic-hodgkin-lymphoma-chl-100529185",false,"NCT06170489","A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)","A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled:\n\n* Age at least 18 years old, both males and females are eligible\n* Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR\u002FPR in recent treatment) or refractory (failure to achieve CR\u002FPR in recent treatment) status.\n* Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)\n* ECOG: 0-2\n* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to the investigational drug or its components\n* Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.\n* Presence of central nervous system (CNS) metastasis.\n* Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)\n* Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years","ALL","18 Years",{"count":69,"type":70},185,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)",[76],"Hodgkin Lymphoma","2025-02-26",{"date":79,"type":80},"2025-02-28","ACTUAL",{"date":82,"type":80},"2023-12-28",{"date":84,"type":70},"2027-09-30",{"name":5,"class":6},1]