[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561981":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":63,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":26,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Proximal radical gastrectomy group","EXPERIMENTAL","Patients with locally advanced upper gastric cancer were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD (Progressive disease) and SD (Stable disease) patients were replaced with conservative treatment or surgical treatment after MDT (Multi-disciplinary Treatment) discussion; (2) For PR (Partial response) and CCR (Clinical complete response) patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, which were divided into experimental group : the group of proximal gastric radical surgery; Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.",[13],"Procedure: Proximal radical gastrectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Total radical gastrectomy group","ACTIVE_COMPARATOR","Patients with untreated, operable locally advanced upper gastric cancer who signed informed consent and met the screening criteria were enrolled for 4 cycles of SOX combined with anti-PD-1 neoadjuvant therapy. After the completion of neoadjuvant therapy, the efficacy was evaluated, and the patients were divided into two groups according to the remission of lesions: (1) PD and SD patients were replaced with conservative treatment or surgical treatment after MDT discussion; (2) For PR and CCR patients, if the patients met the criteria for proximal gastric radical surgery, the enrolled patients were randomly divided into 2 cohorts, Cohort 2 (control group) : total radical gastrectomy group. Four cycles of SOX combined with anti-PD-1 adjuvant therapy continued after surgery, and anti-PD-1 adjuvant therapy lasted for 1 year.",[19],"Procedure: Total radical gastrectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Proximal radical gastrectomy","Proximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon\\'s habit.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Total radical gastrectomy","total radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Guihua Wang","CONTACT","+86-027-83665215","ghwang@tjh.tjmu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"lisheng chen","+86-13797056427","clsmail1990@163.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Tongji Hospital, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.26667,30.58333,{"lat":54,"lon":53},[57],{"name":43,"role":34,"phone":58,"phoneExt":26,"email":59},"+86-027-83662640","ims@tjh.tjmu.edu.cn",{"type":61,"investigatorFullName":33,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Professor",[64,66,68,70,72,74,76,78,80,82,84,86,88,90,92,94,96,98,100,102,105,107,109,111,113,115,117,119,121,123,125,127],{"name":65,"class":6},"Fudan University",{"name":67,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":69,"class":6},"Xiangya Hospital of Central South University",{"name":71,"class":6},"Shandong First Medical University",{"name":73,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":75,"class":6},"The First Medical Center of Chinese PLA General Hospital",{"name":77,"class":6},"Affiliated Hospital of Qinghai University",{"name":79,"class":6},"Qilu Hospital of Shandong University",{"name":81,"class":6},"Ruijin Hospital",{"name":83,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":85,"class":6},"Southern Medical University, China",{"name":87,"class":6},"Shanxi Bethune Hospital",{"name":89,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":91,"class":6},"The Third Xiangya Hospital of Central South University",{"name":93,"class":6},"Jingzhou Central Hospital",{"name":95,"class":6},"Xiangyang Central Hospital",{"name":97,"class":6},"Yichang Central People's Hospital",{"name":99,"class":6},"The First Affiliated Hospital of University of South China",{"name":101,"class":6},"Guangdong Provincial People's Hospital",{"name":103,"class":104},"People's Hospital of Macheng City","UNKNOWN",{"name":106,"class":6},"Southwest Hospital, China",{"name":108,"class":6},"Liaoning Cancer Hospital & Institute",{"name":110,"class":6},"RenJi Hospital",{"name":112,"class":6},"Changhai Hospital",{"name":114,"class":6},"The First Affilated Hospital of the Medical College, Shihezi University",{"name":116,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":118,"class":6},"First Affiliated Hospital of Xinjiang Medical University",{"name":120,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University",{"name":122,"class":6},"First Hospital of China Medical University",{"name":124,"class":6},"Shanghai East Hospital",{"name":126,"class":6},"General Hospital of Ningxia Medical University",{"name":128,"class":6},"Shanghai Changzheng Hospital","100561981","proximal-gastrectomy-vs-total-gastrectomy-in-locally-advanced-upper-gastric-cancer-after-neoadjuvant-therapy-100561981",false,"NCT06597227","Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy","Comparison of Clinical Efficacy of Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined With Anti-PD-1 Neoadjuvant Therapy：a Prospective, Multi-center, Randomised，Controlled Trial","TJHGC01","Inclusion Criteria:\n\n* To be eligible to participate in this study, all patients must meet all the following criteria:\n\n  1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;\n  2. Age 18-75 years old (at the time of signing the informed consent), both male and female;\n  3. Histologically and\u002For cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT\u002FMRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;\n  4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy\u002Fimmunotherapy;\n  5. ECOG score 0-1;\n  6. Expected survival ≥6 months;\n  7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;\n  8. The major organs function well and meet the following criteria:\n\n  \u003C!-- -->\n\n  1. Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g\u002FL; Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet (PLT) ≥80×109\u002FL;\n  2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL\u002Fmin;\n  3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n  4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;\n  5. Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.\n\nExclusion Criteria:\n\n* To be eligible to participate in this study, all patients must meet all the following criteria:\n\n  1. The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;\n  2. Age 18-75 years old (at the time of signing the informed consent), both male and female;\n  3. Histologically and\u002For cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT\u002FMRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;\n  4. Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy\u002Fimmunotherapy;\n  5. ECOG score 0-1;\n  6. Expected survival ≥6 months;\n  7. Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis;\n  8. The major organs function well and meet the following criteria:\n\n  \u003C!-- -->\n\n  1. Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g\u002FL; Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet (PLT) ≥80×109\u002FL;\n  2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL\u002Fmin;\n  3. Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n  4. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;\n  5. Assessed with adequate organ function by doctors. 9. Fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study, have a negative serological pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.","ALL","18 Years","75 Years",{"count":141,"type":142},404,"ESTIMATED","INTERVENTIONAL",[145],"NA","We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer",[148],"Locally Advanced Gastric Cancer",[150,151,152,23,153],"Locally advanced gastric cancer","neoadjuvant chemotherapy","immunotherapy","total radical gastrectomy","2026-04-22",{"date":156,"type":157},"2026-04-27","ACTUAL",{"date":159,"type":157},"2024-03-01",{"date":161,"type":142},"2028-12-30",{"name":33,"class":6},1]