[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478091":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":52,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":31,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant therpy","EXPERIMENTAL","Neoadjuvant chemoradiation plus SOX and PD-1 antibody",[13],"Drug: neoadjuvant Radiation plus SOX and PD-1 antibody",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","neoadjuvant Radiation plus SOX and PD-1 antibody","Patients will be given the perioperative treatment as below once recruited:\n\nFirst, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles.\n\nThe neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable.\n\nSOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery.",[9],[21],"Neoadjuvant Chemoradiotherapy plus Immunotherapy",[23],{"name":24,"affiliation":5,"role":25},"Yingjiang Ye, MD，PhD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Liyu Zhu, MD","CONTACT","+8610-66583821",null,"wcwkzlward@163.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":32},"Jing Zhou, MD","+8610-66583820",[37],{"facility":5,"status":31,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing","Beijing Municipality","100044","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":30,"phoneExt":31,"email":32},"Liyu Zhu",{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"YE Yingjiang","Director of the department of gastrointestinal surgery","100478091","phase-2-neoadjuvant-immunotherapy-and-chemoradiotherapy-for-locally-advanced-esophagogastric-junction-adenocarcinoma-100478091",false,"NCT05505461","Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma","Efficacy and Safety of PD-1 Combined With Long-term Concurrent Neoadjuvant Chemoradiotherapy and Chemotherapy in the Treatment of Resectable Locally Advanced Esophagogastric Junction Adenocarcinoma： A Phase II Study","NICLA","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.\n2. Clinically diagnosed stage T3+orN+M0, according to CT\u002FMRI scan.\n3. No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.\n4. Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.\n5. At least one evaluable lesion in abdominal CT\u002FMRI according to RESIST 1.1 is required.\n6. Expected survival ≥6 months.\n7. Adequate organ function, Hemoglobin ≥90g\u002FL; White blood cells ≥3.0×109\u002FL; neutrophil count ≥1.5×109\u002FL; Platelets ≥100×109\u002FL; Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50ml\u002Fmin (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein must be ≤ 1 g.\n8. Normal coagulation function, no active bleeding and thrombotic diseases: International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;\n9. Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the start of the study medication;\n10. Female patients should not be pregnant or breast feeding. Male should contraception.\n11. Able and willing to give informed consent to participate.\n12. Those who are expected to have good compliance.\n\nExclusion Criteria:\n\n1. Existence of other active malignant tumors within 5 years or at the same time.\n2. Already received chemotherapy, radiation therapy, targeted or immunotherapy.\n3. Have any active autoimmune disease or history of autoimmune disease.\n4. Patients with congenital or acquired immunodeficiency.\n5. Use of immunosuppressive drugs within 14 days before the study start.\n6. Administer live attenuated vaccines within 4 weeks before the study start.\n7. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia.\n8. Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.\n9. Suffering from active pulmonary tuberculosis.\n10. Complicated severe infection within 4 weeks before the the study start, or unexplained fever \\>38.5°C during the screening period\u002Fbefore the study start.\n11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n13\\. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.\n\n15.Participators who had been recruited by other clinical trial within three months.","ALL","18 Years","75 Years",{"count":67,"type":68},26,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.",[74],"Adenocarcinoma of Esophagogastric Junction",[76],"PD-1, neoadjuvant therapy, radiotherapy","NOT_YET_RECRUITING","2022-08-15",{"date":80,"type":81},"2022-08-17","ACTUAL",{"date":83,"type":68},"2023-01",{"date":85,"type":68},"2027-12",{"name":5,"class":6},1]