[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer-peritoneal-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer-peritoneal-metastases":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Gastric Cancer Peritoneal Metastases",[28,29,30],"HIPEC","NIPS","PD-1","NOT_YET_RECRUITING","2025-12-12",{"date":34,"type":35},"2025-12-26","ACTUAL",{"date":32,"type":20},{"date":38,"type":20},"2027-12-31",{"name":40,"class":41},"Hebei Medical University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100616335","phase-3-intraperitoneal-paclitaxel-and-systemic-therapy-versus-systemic-therapy-alone-in-gastric-cancer-patients-with-peritoneal-metastasis-100616335","NCT07304271","Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis","Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric","IPa-Gastric","Inclusion Criteria:\n\n* Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour\n* Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid\n* Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.\n* Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy.\n* Adequate hematology assessment and serum chemistry\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Age of at least 18 years\n* Life expectancy of at least three months\n* Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable\n\nExclusion Criteria:\n\n* Comorbidity that does not allow treatment with ST or IP paclitaxel\n* Confirmed or suspected severe abdominal adhesions\n* Severe coagulation disorder which precludes surgical interventions\n* Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases\n* Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term\n* Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery\n* Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to 2 cycles of first line chemotherapy is allowed). Perioperative chemotherapy within previous curative context is allowed\n* Another malignancy that can affect survival within the next three years\n* Known or suspected allergies against any product included in the trial interventions\n* DYPD deficiency\n* Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding\n* Active sex-life without use of secure contraceptive method.\n* If the investigator considers the patient inappropriate for participation in the study for any other reason\n* Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product",{"count":52,"type":20},262,[54],"PHASE3","The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.",[26],[58,59,60],"Gastric cancer","Peritoneal metastasis","Intraperitoneal administration","RECRUITING",{"date":34,"type":35},{"date":64,"type":35},"2025-11-05",{"date":66,"type":20},"2031-01-31",{"name":68,"class":41},"Magnus Nilsson",5]