[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100282788":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":69,"locations":79,"responsibleParty":117,"collaborators":29,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":29,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":29,"studyType":134,"phases":135,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":82,"whyStopped":29,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-PD-1 antibody+decitabine","EXPERIMENTAL","Decitabine will be administrated at 10mg\u002Fd on day1 to 5, followed by Anti-PD-1 antibody 200mg on day8 IV Q3 weeks until progression.",[13,14],"Drug: Anti-PD-1 antibody","Drug: Decitabine",{"label":16,"type":10,"description":17,"interventionNames":18},"Anti-PD-1 antibody","Anti-PD-1 antibody 200mg IV Q3 weeks until progression.",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Anti-PD-1 antibody+chemotherapy","Chemotherapy will be given depends on the cancer type and treatment regimen before enrollment. Chemotherapy was administrated on day1 , followed by Anti-PD-1 antibody 200mg on day2 IV Q3 weeks until progression. Following disease remission, radiotherapy could be administered or omitted for consolidation at the discretion of the investigator.",[13,23],"Drug: Chemotherapy",[25,30,34],{"type":26,"name":16,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Anti-PD-1 antibody will be given at 1-3mg\u002Fkg on day8 by IV every three weeks",[16,20,9],null,{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Decitabine","Decitabine will be given at 10mg\u002Fd on day 1to 5 by IV every three weeks",[9],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Chemotherapy","Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.",[20],[39,43,45,47,49,52,55,57,59,61,63,65,67],{"name":40,"affiliation":41,"role":42},"Chunmeng Wang, Master","Biotherapeutic Department of Chinese PLA General Hospital, Beijing, China, 100853","STUDY_DIRECTOR",{"name":44,"affiliation":41,"role":42},"Wenying Zhang, Master",{"name":46,"affiliation":41,"role":42},"Yang Liu, Doctor",{"name":48,"affiliation":41,"role":42},"Meixia Chen, Doctor",{"name":50,"affiliation":41,"role":51},"Yan Zhang, Doctor","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":54,"role":42},"Qian Mei, Doctor","Department of Molecular Biology, Institute of Basic Medicine, Chinese PLA General Hospital, Beijing, 100853, China.",{"name":56,"affiliation":54,"role":42},"Jing Nie, Doctor",{"name":58,"affiliation":54,"role":51},"Xiang Li, Master",{"name":60,"affiliation":54,"role":51},"Liang Dong, Master",{"name":62,"affiliation":54,"role":51},"Lu Shi, Master",{"name":64,"affiliation":41,"role":51},"Kaichao Feng, Doctor",{"name":66,"affiliation":41,"role":51},"Jingdan Qiu, Doctor",{"name":68,"affiliation":41,"role":51},"Hejin Jia, Doctor",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":29,"email":74},"Weidong Han, doctor","CONTACT","+86-010-66937463","hanwdrsw@sina.com",{"name":76,"role":72,"phone":77,"phoneExt":29,"email":78},"Qingming Yang, doctor","+86-010-55499341","yangqm@medmail.com.cn",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Biotherapeutic Department of Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":89,"coordinates":90},"Point",[91,92],116.39723,39.9075,{"lat":92,"lon":91},[95,98,101,102,103,104,105,106,107,108,109,111,112,113,114,115,116],{"name":96,"role":72,"phone":97,"phoneExt":29,"email":74},"Weidong Han, Doctor","+86-10-66937463",{"name":99,"role":72,"phone":100,"phoneExt":29,"email":78},"Qingming Yang, Doctor","+86-10-55499341",{"name":46,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":40,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":44,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":48,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":96,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":99,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":53,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":56,"role":51,"phone":29,"phoneExt":29,"email":29},{"name":50,"role":110,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"name":64,"role":110,"phone":29,"phoneExt":29,"email":29},{"name":66,"role":110,"phone":29,"phoneExt":29,"email":29},{"name":68,"role":110,"phone":29,"phoneExt":29,"email":29},{"name":58,"role":110,"phone":29,"phoneExt":29,"email":29},{"name":60,"role":110,"phone":29,"phoneExt":29,"email":29},{"name":62,"role":110,"phone":29,"phoneExt":29,"email":29},{"type":118,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Han weidong","Principal Investigator","100282788","phase-1-anti-pd-1-antibody-alone-or-in-combination-with-decitabinechemotherapy-in-relapsed-or-refractory-malignancies-100282788",false,"NCT02961101","Anti-PD-1 Antibody Alone or in Combination With Decitabine\u002FChemotherapy in Relapsed or Refractory Malignancies","Anti-PD-1 Antibody Alone or in Combination With Low-dose Decitabine and\u002For Chemotherapy in Relapsed or Refractory Malignancies: an Open-label Phase I\u002FII Trial","Inclusion Criteria:\n\n1. Subjects must have histological confirmation of relapsed or refractory malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.\n2. 12 to 75 years of age.\n3. ECOG performance of less than 2.\n4. Life expectancy of at least 3 months.\n5. Subjects with lymphoma must have at least one measureable lesion \\>1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion \\>1 cm per RECIST1.1.\n6. Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.\n7. Subjects must have adequate bone marrow, live, renal, lung and heart functions.\n\n   1. Absolute neutrophil count greater than or equal to 1,000\u002FμL.\n   2. Platelet count greater than or equal to 70,000\u002FµL.\n   3. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).\n   4. Serum creatinine less than or equal to 1.5 x ULN.\n   5. Alanine aminotransferase \\[ALT or SGPT\\] and aspartate aminotransferase \\[AST or SGOT\\] less than or equal to 2.5 x ULN.\n\nExclusion Criteria:\n\n1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.\n2. Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.\n3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .\n4. Prior organ allograft.\n5. Women who are pregnant or breastfeeding.\n6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.","ALL","12 Years","75 Years",{"count":132,"type":133},250,"ESTIMATED","INTERVENTIONAL",[136,137],"PHASE1","PHASE2","The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1 antibody alone or in combination with low-dose decitabine in patients with relapsed or refractory malignancies, including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.",[140],"Malignancies Multiple",[142,143,144,145,146],"relapsed or refractory","malignancies","decitabine","anti-PD-1 antibody","chemotherapy","2026-01-21",{"date":149,"type":150},"2026-01-22","ACTUAL",{"date":152,"type":29},"2016-05",{"date":154,"type":133},"2026-05",{"name":119,"class":6},1]