[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530745":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":61,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1 inhibitor+\u002F- chemotherapy combined with local therapy","EXPERIMENTAL","Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)",[13],"Combination Product: PD-1 inhibitor+\u002F- chemotherapy combined with local therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"PD-1 inhibitor +\u002F- chemotherapy alone","ACTIVE_COMPARATOR","Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)",[19],"Drug: systemic therapy alone",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","1. PD-1 inhibitor +\u002F- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable\n\n   First line:\n\n   i. TP: paclitaxel 135-175mg\u002Fm2,d1+ DDP25mg\u002Fm2, d1-3 or 75mg\u002Fm2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)\n2. Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy\u002F6fx; for spine metastatic disease 30Gy\u002F10Fx; for brain metastases 24Gy\u002F30fx; IMRT: for bone metastatic disease 30Gy\u002F10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy\u002F28fx; ii. Surgery iii. Radiofrequency\u002Fmicrowave ablation",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","systemic therapy alone","1.PD-1 inhibitor +\u002F- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable\n\nFirst line:\n\ni. TP: paclitaxel 135-175mg\u002Fm2,d1+ DDP25mg\u002Fm2, d1-3 or 75mg\u002Fm2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)",[15],[32],"the systemic therapy only",[34],{"name":35,"affiliation":5,"role":36},"Kuaile Zhao, MD","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Qi Liu, MD","CONTACT","86-18017317882","18017317882@163.com",{"name":35,"role":40,"phone":44,"phoneExt":25,"email":45},"86-18017312534","kuaile_z@sina.com",[47],{"facility":48,"status":49,"city":50,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Fudan University Shanghai cancer center","RECRUITING","Shanghai","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60],{"name":35,"role":40,"phone":44,"phoneExt":25,"email":45},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Kuai Le Zhao, MD","professor","100530745","phase-3-local-therapy-for-oligometastatic-escc-patients-treated-with-pd-1-inhibitor-100530745",false,"NCT06190782","Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor","Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1\\. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO\u002FESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases\n\nExclusion Criteria:\n\n* 1\\. History of disseminated metastases or ASTRO\u002FESTRO defined induced oligometastatic disease 2.Esophageal perforation\u002Fhemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\\>25%","ALL","18 Years",{"count":75,"type":76},354,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +\u002F- chemotherapy combined with local therapy or PD-1 inhibitor +\u002F- chemotherapy alone.\n\nThe primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.",[82,83,84],"Esophageal Squamous Cell Carcinoma","Oligometastatic Disease","Radiotherapy",[86,87,84,88],"esophageal squamous cell carcinom","Oligometastatic","pd-1 inhibitor","2024-04-30",{"date":91,"type":92},"2024-05-02","ACTUAL",{"date":94,"type":92},"2022-09-27",{"date":96,"type":76},"2027-09-27",{"name":5,"class":6},1]