[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522733":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":50,"locations":60,"responsibleParty":81,"collaborators":83,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":54,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":54,"enrollmentInfo":125,"targetDuration":54,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":63,"whyStopped":54,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1 inhibitor plus chemotherapy arm","ACTIVE_COMPARATOR","Drugs: TP or PF regimen depended on investigator's choice. A maximum of six cycles was recommended for chemotherapy.\n\nBiological: PD-1 inhibitor (Camrelizumab).",[13,14],"Drug: TP or PF regimen depended on investigator's choice.","Biological: PD-1 inhibitor",{"label":16,"type":17,"description":18,"interventionNames":19},"Radiotherapy arm","EXPERIMENTAL","Radiation: Intensity-modulated Radiation Therapy\u002FVolumetric Modulated Arc Therapy (IMRT\u002FVMAT) technique. Patients will receive radiotherapy between the first and third cycle of chemotherapy.\n\nDrugs: TP or PF regimen depended on investigator's choice. Biological: PD-1 inhibitor (Camrelizumab).",[20,13,14],"Radiation: Radiation",[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Radiation","IMRT\u002FVMAT technique. Patients receive radiotherapy once daily, 5 days a week for an average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 50Gy in 25 fractions to planning gross tumor volume (PGTV) with involved site included.",[16],[28],"Modern intensity modulated radiotherapy",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","TP or PF regimen depended on investigator's choice.","A maximum of six cycles was recommended for chemotherapy. Chemotherapy Regimen 1(TP regimen A): Nab-paclitaxel(Albumin-bound paclitaxel) 110-130mg\u002F m2，d1，d8; Cisplatin 60-75mg\u002F m2，d1；Q3W； Chemotherapy Regimen 2 (TP regimen B): Paclitaxel 150-175 mg\u002Fm2, d1; Cisplatin 60-75mg\u002F m2，d1；Q3W； PD-1 inhibitor 200mg, d1, Q3W Chemotherapy Regimen 3 (PF regimen): Capecitabine 800mg\u002Fm2, bid, d1-14; Cisplatin 25-30mg\u002Fm2, d1,d2, Q3W.",[9,16],[35],"Chemotherapy",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BIOLOGICAL","PD-1 inhibitor","Camrelizumab (200mg, d1, Q3W) was continued until disease progression, unacceptable toxicity, death, physician or patient decision to withdraw, non-compliance, or discontinuation for administrative reasons (up to 35 cycles).",[9,16],[42],"Camrelizumab",[44,48],{"name":45,"affiliation":46,"role":47},"Lin Shen, MD","Peking University Cancer Hospital & Institute","PRINCIPAL_INVESTIGATOR",{"name":49,"affiliation":5,"role":47},"Wen-Yang Liu, MD",[51,56],{"name":49,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","8601087787625",null,"liuwenyang@cicams.ac.cn",{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},"Zhi-Hao Lu, MD","86-10-88196561","pppeirain@126.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Cancer hospital, CAMS","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76,77,79],{"name":49,"role":52,"phone":54,"phoneExt":54,"email":55},{"name":54,"role":52,"phone":54,"phoneExt":78,"email":55},"Liu",{"name":80,"role":47,"phone":54,"phoneExt":54,"email":54},"Wen-Yang Liu",{"type":82,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR",[84,85,87,89,91,94,96,98,100,102,104,106,108,110,112,114],{"name":46,"class":6},{"name":86,"class":6},"Beijing Cancer Prevention & Treatment Society",{"name":88,"class":6},"Hebei Medical University Fourth Hospital",{"name":90,"class":6},"Tianjin Medical University Cancer Institute and Hospital",{"name":92,"class":93},"Fujian Cancer Hospital","OTHER_GOV",{"name":95,"class":6},"Anyang Tumor Hospital",{"name":97,"class":6},"The First Affiliated Hospital with Nanjing Medical University",{"name":99,"class":6},"Sichuan Cancer Hospital and Research Institute",{"name":101,"class":93},"Tengzhou Central People's Hospital",{"name":103,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":105,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":107,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":109,"class":6},"Second Affiliated Hospital of Xi'an Jiaotong University",{"name":111,"class":6},"Affiliated Hospital of North Sichuan Medical College",{"name":113,"class":6},"Changzhou Cancer Hospital of Soochow University",{"name":115,"class":93},"Henan Cancer Hospital","100522733","phase-3-pd-1-inhibitor-plus-chemotherapy-with-or-without-radiotherapy-in-patients-with-metastatic-esophageal-cancer-100522733",false,"NCT06086457","PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer","PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer: A Randomized Multicenter Phase III Trial","Inclusion Criteria:\n\n* 1\\. ≥18 years, any gender\n* 2\\. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 8th Edition) , with distant metastasis involving no more than 2 organs (lymph node metastasis is counted);\n* 3\\. ECOG (Eastern Cooperative Oncology Groupper) formance status \\\u003C= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final evaluation is good;\n* 4.There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;\n* 5.No prior history of thoracic radiation;\n* 6.Expected survival is more than 12 weeks;\n* 7.Informed consent provided.\n\nExclusion Criteria:\n\n* 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.\n* 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；\n* 3\\. Active infection currently exists . The following conditions occurred within 6 months before randomization: myocardial infarction, cerebrovascular accident, or received gastrointestinal, neurological, cardiopulmonary surgery;\n* 4\\. History of allergy to chemotherapy drugs or autoimmune disease;\n* 5\\. Participate in other clinical trials at present or within 4 weeks before enrollment;\n* 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.","ALL","18 Years",{"count":126,"type":127},436,"ESTIMATED","INTERVENTIONAL",[130],"PHASE3","The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently.\n\nOn this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer.\n\nAccompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.",[133],"Esophageal Neoplasms",[135,38],"Radiotherapy","2024-07-12",{"date":138,"type":139},"2024-07-16","ACTUAL",{"date":141,"type":139},"2024-02-04",{"date":143,"type":127},"2029-08-28",{"name":5,"class":6},1]