[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475062":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":41,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab combined with FLOT regimen","EXPERIMENTAL","The enrolled patients will receive 3 cycles of FLOT regimen +Toripalimab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). After completing the 3 cycles of treatment, the patient undergoes surgical resection.Toripalimab combined with FLOT regimen were maintained for 4 cycles after surgery.",[13],"Drug: Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)","FLOT: Docetaxel 50mg\u002Fm2 ivd d1 + oxaliplatin 85mg\u002Fm2 ivd d1 + leucovorin 200mg\u002Fm2 ivd d1 + 5-FU 2600mg\u002Fm2 civ, Q2W Toripalimab 3mg\u002Fkg, intravenously administered on the first day of each cycle, Q2W.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":20,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"First Hospital of Jilin University","RECRUITING","Changchun","Jilin","China","CN",{"type":30,"coordinates":31},"Point",[32,33],125.32278,43.88,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Quan Wang, phD","CONTACT","15843073207","wquan@jlu.edu.cn",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Quan Wang","Professor","100475062","phase-2-a-prospective-single-center-clinical-study-of-toripalimab-combined-with-flot-regimen-for-perioperative-treatment-of-pd-l1-positive-locally-advanced-resectable-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-gej-100475062",false,"NCT05466019","A Prospective, Single Center Clinical Study of Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ)","Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ): a Prospective, Single-center Clinical Study","Inclusion Criteria:\n\n1. Informed consent of the patient;\n2. 18 years old \\\u003Cage \\\u003C75 years old;\n3. The researcher judged that he could comply with the study protocol;\n4. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);\n5. Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)\n\n   * Esophagogastroduodenoscopy must be performed\n   * Diagnostic laparoscopy must be performed\n6. Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1);\n7. Preoperative ECOG \\[Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)\\] Physical State Score 0\u002F1;\n8. Preoperative ASA score I-III;\n9. Expected survival ≥12 weeks;\n10. The baseline blood routine and biochemical parameters of selected patients should meet the following criteria:\n\n    * Hemoglobin ≥90g\u002F L, which can be met by blood transfusion;\n    * Absolute neutrophil count ≥1.5×10\\^9\u002F L\n    * Platelet count ≥100×10\\^9\u002F L\n    * Aspartic acid or alanine aminotransferase ≤ 2.5 times the upper limit\n    * Alkaline phosphatase ≤ 2.5 times normal upper limit (ULN),\n    * Thyroid stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time; if T3 and T4 levels are normal, they can be included in the group);\n\nExclusion Criteria:\n\n1. Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma\n2. Previous systemic treatment for gastric cancer\n3. Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine;\n4. Received any of the following medical treatment:\n\n   A. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past; B. Have received any investigational drug treatment within 4 weeks before using the drug for the first time; C. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; D. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;; E. Receive systematic treatment with corticosteroids (\\> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to their first use of the study drug; F. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; G. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time;\n5. History of other malignant diseases within 5 years;\n6. History of active autoimmune disease or autoimmune disease\n7. The subject has cardiovascular clinical symptoms or disease that is not well controlled;\n8. Severe infection 4 weeks prior to first use of study drug (CTCAE \\> Level 2)\n9. A history of interstitial lung disease (except for radiation pneumonia not treated with Chinese hormone) or non-infectious pneumonia;\n10. Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 year ago but without formal treatment;\n11. Pregnant or lactating women;\n12. Suffering from severe mental illness.","ALL","18 Years","75 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .",[63],"PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer","UNKNOWN","2022-07-18",{"date":67,"type":68},"2022-07-20","ACTUAL",{"date":70,"type":68},"2021-05-01",{"date":72,"type":57},"2024-12-01",{"name":5,"class":6},1]