[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616334":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":28,"studyPopulation":28,"armGroups":38,"interventions":46,"overallOfficials":28,"centralContacts":28,"locations":61,"responsibleParty":80,"collaborators":28,"id":83,"slug":28,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":28,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":102,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hebei Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Surgical Conversion Rate","Proportion of R0 Resection Patients in the ITT Population","The day of surgery",[14,18,22,26,29],{"measure":15,"description":16,"timeFrame":17},"1-year PFS rate","Proportion of patients without disease progression or death for at least 1 year from treatment initiation","1 year",{"measure":19,"description":20,"timeFrame":21},"2-year OS rate","Proportion of patients surviving for at least 2 years from treatment initiation","2 years",{"measure":23,"description":24,"timeFrame":25},"Progression-free survival（PFS）","Time from enrollment to disease progression or death","3 years",{"measure":27,"description":28,"timeFrame":25},"Overall survival (OS)",null,{"measure":30,"description":31,"timeFrame":25},"Adverse events","Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests",{"allocation":33,"interventionModel":34,"interventionModelDescription":28,"primaryPurpose":35,"observationalModel":28,"timePerspective":28,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":28,"whoMasked":28},"NONE",[39],{"label":40,"type":41,"description":28,"interventionNames":42},"Arm A","EXPERIMENTAL",[43,44,45],"Device: HIPEC","Device: NIPS","Drug: Paclitaxel Injection, S-1, tislelizumab",[47,52,56],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":28},"DEVICE","HIPEC","HIPEC protocol: Paclitaxel Injection, 75mg\u002Fm², D1, D3, D5, for three cycles, followed by a two-week rest before initiating NIPS combined with systemic therapy.",[40],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":28},"NIPS","Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg\u002Fm² on D1 and D8; Q3W.",[40],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":28},"DRUG","Paclitaxel Injection, S-1, tislelizumab","Paclitaxel Injection: 50mg\u002Fm², iv, D1, D8; Q3W; Tegafur Gimeracil Oteracil Potassium Capsules (S-1):For body surface area (BSA) \\\u003C1.25, 40mg per dose; BSA ≥1.25 to \\\u003C1.5, 50mg per dose; BSA ≥1.5, 60mg per dose; po, bid, D1-D14; Q3W; Tislelizumab: 200mg per administration, intravenous drip over 30 minutes (not less than 20 minutes and not exceeding 60 minutes), D1, Q3W.",[40],[62],{"facility":63,"status":28,"city":64,"state":65,"zip":28,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fourth Affiliated Hospital of Hebei Medical University","Shijiazhuang","Hebei","China","CN",{"type":69,"coordinates":70},"Point",[71,72],114.47861,38.04139,{"lat":72,"lon":71},[75],{"name":76,"role":77,"phone":78,"phoneExt":28,"email":79},"Qun Zhao","CONTACT","13930162111","zhaoqun516@126.com",{"type":81,"investigatorFullName":76,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100616334",false,"NCT07304258","A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10","Inclusion Criteria:\n\n1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;\n2. Age between 18 and 75 years;\n3. Male or non-pregnant, non-lactating female;\n4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;\n5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;\n6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);\n7. No other distant metastases;\n8. Hematological criteria: white blood cell count ≥3.5×10⁹\u002FL, neutrophils ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL;\n9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;\n10. Left ventricular ejection fraction ≥50%;\n11. ECOG performance status 0-1;\n12. Ability to comply with the study protocol and voluntarily provide signed informed consent.\n\nExclusion Criteria:\n\n1. Inability to comply with the study protocol or procedures;\n2. Known HER2-positive status;\n3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;\n4. Current conditions or diseases affecting drug absorption;\n5. Patients preoperatively confirmed as unsuitable for conversion therapy;\n6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;\n7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and\u002For progressive growth);\n8. Known allergy to the investigational drug(s);\n9. Prior treatment with anti-PD-1\u002FPD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs\u002Fantibodies targeting T-cell co-stimulation or checkpoint pathways;\n10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive);\n11. Significant malnutrition (weight loss ≥5% within 1 month or \\>15% within 3 months prior to informed consent, or food intake reduced by ≥50% within 1 week), unless corrected for ≥4 weeks before the first dose of investigational drug;\n12. History of other primary malignancies, except:\n\n    * Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study;\n    * Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence;\n    * Adequately treated carcinoma in situ with no evidence of recurrence;\n13. Female patients who are pregnant or breastfeeding;\n14. Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;\n15. Patients deemed ineligible for the study by the investigator.","ALL","18 Years","75 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This study aims to evaluate the efficacy and safety of HIPEC combined with NIPS and tislelizumab conversion therapy for gastric\u002Fgastroesophageal junction cancer with positive cytology alone (CY1P0) or a Peritoneal Carcinomatosis Index (PCI) ≤10",[99],"Gastric Cancer Peritoneal Metastases",[49,53,101],"PD-1","NOT_YET_RECRUITING","2025-12-12",{"date":105,"type":106},"2025-12-26","ACTUAL",{"date":103,"type":93},{"date":109,"type":93},"2027-12-31",{"name":5,"class":6},1]