[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624359":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":35,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":11,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Jiangsu Cancer Institute & Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy combined with Tislelizumab","EXPERIMENTAL",null,[13,14],"Drug: Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy","Device: low-dose radiotherapy",{"label":16,"type":17,"description":11,"interventionNames":18},"Chemotherapy","ACTIVE_COMPARATOR",[19],"Drug: Chemotherapeutic Agent",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Low Dose Radiotherapy Combined with Tislelizumab and Chemotherapy","Chemotherapy: Oxaliplatin 130 mg\u002Fm² on days 1 and 22 plus capecitabine 1000 mg\u002Fm² twice daily on days 1-14, for a total of 3 cycles.Tislelizumab: 200 mg administered concurrently with chemotherapy on days 1 and 22 via intravenous infusion, for a total of 3 cycles. Low Dose Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Chemotherapeutic Agent","Chemotherapy: Oxaliplatin 130 mg\u002Fm² on days 1 and 22 plus capecitabine 1000 mg\u002Fm² twice daily on days 1-14, for a total of 3 cycles.",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DEVICE","low-dose radiotherapy","Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.",[9],{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Gang Li","Clinical Professor","100624359","phase-2-perioperative-chemotherapy-with-low-dose-radiotherapy-and-tislelizumab-for-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100624359",false,"NCT07408609","Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase II Multicenter Randomized Controlled Trial of Perioperative Chemotherapy Combined With Low-Dose Radiotherapy and Tislelizumab Versus Chemotherapy Alone in Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II\u002FIII) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and\u002For non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.\n\nExclusion Criteria:\n\n1. History of surgery for gastric or gastroesophageal junction tumors;\n2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;\n\n4.Poor nutritional status, defined as BMI \\\u003C18.5 kg\u002Fm² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1\u002FPD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade \\>1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.","ALL","20 Years","80 Years",{"count":50,"type":51},114,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.",[57],"Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-02-12",{"date":61,"type":62},"2026-02-13","ACTUAL",{"date":64,"type":51},"2026-02-26",{"date":66,"type":51},"2031-02-20",{"name":5,"class":6}]