[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616334":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":11,"locations":31,"responsibleParty":50,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hebei Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL",null,[13,14,15],"Device: HIPEC","Device: NIPS","Drug: Paclitaxel Injection, S-1, tislelizumab",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"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.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"NIPS","Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg\u002Fm² on D1 and D8; Q3W.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"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.",[9],[32],{"facility":33,"status":11,"city":34,"state":35,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fourth Affiliated Hospital of Hebei Medical University","Shijiazhuang","Hebei","China","CN",{"type":39,"coordinates":40},"Point",[41,42],114.47861,38.04139,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Qun Zhao","CONTACT","13930162111","zhaoqun516@126.com",{"type":51,"investigatorFullName":46,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100616334","phase-2-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-10-100616334",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":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"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",[70],"Gastric Cancer Peritoneal Metastases",[19,23,72],"PD-1","NOT_YET_RECRUITING","2025-12-12",{"date":76,"type":77},"2025-12-26","ACTUAL",{"date":74,"type":64},{"date":80,"type":64},"2027-12-31",{"name":5,"class":6},1]