[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516784":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":21,"responsibleParty":38,"collaborators":21,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":21,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":21,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":62,"whyStopped":21,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":21},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT Combined With Zimberelimab","EXPERIMENTAL","Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab",[13,14],"Radiation: Stereotactic body radiation(SBRT)","Drug: Zimberelimab (GLS-010)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Stereotactic body radiation(SBRT)","SBRT: 7-10 Gy\u002FF, 5 doses\n\nZimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Zimberelimab (GLS-010)","Zimberelimab (GLS-010),240mg d1 iv Q21D",[9],[28],"Immunotherapy",[30],{"name":31,"affiliation":5,"role":32},"Junjie Wang, M.D.","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":21,"email":37},"CONTACT","+8613701076310","wangjunjie_puth@163.com",{"type":39,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100516784","phase-2-sbrt-combined-with-zimberelimab-gls-010-in-locally-advanced-pancreatic-cancer-spark-1-study-100516784",false,"NCT06009029","SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)","A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)","Inclusion Criteria:\n\n* 18-75 years old.\n* Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* The expected survival ≥ 3 months.\n* At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.\n* Patient must have adequate organ function defined by the study-specified laboratory tests.\n\nExclusion Criteria:\n\n* Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.\n* Woman who are pregnant or breastfeeding.\n* Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.\n* Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Contraindications to immunotherapy.\n* Other conditions that investigator decides not suitable for the trial.","ALL","18 Years","75 Years",{"count":51,"type":52},96,"ESTIMATED","INTERVENTIONAL",[55],"PHASE2","This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).",[58],"Locally Advanced Pancreatic Cancer",[58,60,61],"SBRT","Zimberelimab","NOT_YET_RECRUITING","2023-08-22",{"date":65,"type":66},"2023-08-24","ACTUAL",{"date":68,"type":52},"2023-08",{"date":70,"type":52},"2027-07",{"name":5,"class":6}]