[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550481":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":54,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":23,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":23,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":23,"overallStatus":78,"whyStopped":23,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surufatinib，sintilimab and SOX chemotherapy","EXPERIMENTAL","Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\\~60mg Bid, d1\\~14, q3w; Oxaliplatin: 130mg\u002Fm2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.",[13,14,15,16],"Drug: Surufatinib","Drug: Sintilimab","Drug: Oxaliplatin","Drug: S1",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Surufatinib","Surufatinib: 250mg qd，d1-21, q3w",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Sintilimab","Sintilimab：200mg ivdrip, d1, q3w",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Oxaliplatin","130mg\u002Fm2，iv drip for 2h，d1, q3w",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"S1","S1：40\\~60mg Bid，d1\\~14, q3w",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Fenglin Liu, MD","CONTACT","13918765733","18916871096@189.cn",[43],{"facility":44,"status":23,"city":45,"state":23,"zip":23,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":23},"Fudan University Cancer Hospital","Shanghai","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Fenglin Liu","MD PhD","100550481","phase-2-perioperative-surufatinib-plus-sintilimab-combined-with-chemotherapy-in-gastricgastroesophageal-junction-adenocarcinoma-100550481",false,"NCT06447636","Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric\u002FGastroesophageal Junction Adenocarcinoma","Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial","Inclusion Criteria:\n\n* signed informed consent\n* patients age 18-75 years;\n* Histologically CT\u002FMRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;\n* ECOG 0-1, no surgery contraindications;\n* Expected survival ≥3 months;\n\nExclusion Criteria:\n\n* signs of distant metastases\n* Prior chemotherapy, radiotherapy, surgery for gastric cancer;\n* Significant cardiovascular disease\n* major surgical procedure within 4 weeks prior to initiation of study treatment\n* current treatment with anti-viral therapy or HBV\n* pregnancy or breastfeeding\n* history of malignancy within 5 years prior to screening\n* Present or history of any autoimmune disease or immune deficiency;\n* Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;\n* There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.\n* Poorly controlled hypertension or diabetes;","ALL","18 Years","75 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.",[76,77],"Gastric Cancer","Gastro Esophageal Junction Cancer","NOT_YET_RECRUITING","2024-06-03",{"date":81,"type":82},"2024-06-07","ACTUAL",{"date":84,"type":70},"2024-08-01",{"date":86,"type":70},"2028-08",{"name":5,"class":6},1]