[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658660":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":37,"overallOfficials":37,"centralContacts":47,"locations":53,"responsibleParty":69,"collaborators":37,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":37,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":37,"studyType":86,"phases":37,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":55,"whyStopped":37,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Ascites objective response rate (ORR)","The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.","1 year",[14,17,20,23,26,30,34],{"measure":15,"description":16,"timeFrame":12},"Overall Survival (OS)","OS is calculated from diagnosis to death or last follow-up time",{"measure":18,"description":19,"timeFrame":12},"Progress free survival (PFS)","PFS is defined as the time from the date of treatment to the first date of disease",{"measure":21,"description":22,"timeFrame":12},"12 months os rate","The definition of 12-months OS rate is the percentage of patients who had NOT has an event before or at 12 months",{"measure":24,"description":25,"timeFrame":12},"Safety assessment","Number and percentage of participants with Adverse Events (any Grade and Grade 3\u002F4)",{"measure":27,"description":28,"timeFrame":29},"Dynamics of Peripheral Blood Biomarkers","Changes in blood-based biomarker levels will be measured. Peripheral blood samples will be used for: 1) Immunophenotyping: The frequency of key immune cell subsets (e.g., CD4+\u002FCD8+ T cells) in PBMCs will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) Plasma Multi-omics: Proteins and metabolites will be profiled using proteomics and metabolomics platforms, respectively. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.","Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months",{"measure":31,"description":32,"timeFrame":33},"Biomarkers in Tumor Tissue","tumor tissue samples will be used for: 1) Immunophenotyping: The frequency of multiple cell subsets in fresh tumors will be analyzed by single-cell transcriptome sequencing. 2) Paraffin sections: used for immunohistochemistry and immunofluorescence. Data will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.3）Single-cell transcriptome sequencing.","Baseline; prior to Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months",{"measure":35,"description":36,"timeFrame":29},"Dynamics of Ascites Biomarkers","Changes in ascites-based biomarker levels will be measured. Ascites samples will be used for: 1) Cell clustering: The frequency of multiple cell subsets in ascites will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) ascites multi-omics: Proteins and metabolites of ascites supernatant will be profiled using ELISA, proteomics, metabolomics platforms, and etc. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","Peritoneal metastasis is common in advanced gastric cancer and is associated with malignant ascites and poor prognosis. The efficacy of anti-PD-1 therapy combined with chemotherapy in this population remains insufficiently characterized, and reliable predictive biomarkers are lacking. This prospective, single-center, observational study conducted in China plans to enroll approximately 50 patients with previously untreated, unresectable advanced or metastatic gastric or gastroesophageal junction (GC\u002FGEJ) adenocarcinoma with malignant ascites. Patients will receive anti-PD-1 therapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment.\n\nClinical efficacy and safety will be evaluated using ascites objective response rate, progression-free survival, overall survival, 12-month overall survival rate, and treatment-related adverse events. Tumor tissue, peripheral blood, and ascites will be collected at baseline, prior to Cycle 2 or Cycle 3 of treatment, and at disease progression when available. Multi-omics analyses, including single-cell transcriptomics, spatial transcriptomics, proteomics, metabolomics, flow cytometry, and related assays, will be performed to identify potential predictive biomarkers and explore an integrated model for predicting treatment response.","Patients with previously untreated, unresectable advanced or metastatic gastric or gastroesophageal junction (GC\u002FGEJ) adenocarcinoma with malignant ascites. Eligible patients will receive first-line anti-PD-1 immunotherapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel.",[44],{"label":45,"type":37,"description":46,"interventionNames":37},"Advanced GC\u002FGEJ With Malignant Ascites","Patients with untreated advanced or metastatic GC\u002FGEJ adenocarcinoma with malignant ascites receiving first-line anti-PD-1 therapy plus systemic chemotherapy and intraperitoneal nab-paclitaxel.",[48],{"name":49,"role":50,"phone":51,"phoneExt":37,"email":52},"Jieer Ying, Dr","CONTACT","13858195803","jieerying@aliyun.com",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":62,"coordinates":63},"Point",[64,65],120.16142,30.29365,{"lat":65,"lon":64},[68],{"name":49,"role":50,"phone":51,"phoneExt":37,"email":52},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Ying Jieer","Principal Investigator","100658660","anti-pd-1-in-combination-with-systemic-chemotherapy-with-nab-paclitaxel-intraperitoneal-infusion-for-untreated-advanced-gastric-cancer-with-malignant-ascites-100658660",false,"NCT07855640","Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites","Anti-PD-1 Therapy Combined With Systemic Chemotherapy and Intraperitoneal Nab-paclitaxel as First-line Treatment for Advanced Gastric Cancer With Malignant Ascites: An Exploratory Study of Efficacy and Predictive Biomarkers","Inclusion Criteria:\n\n\\- Have fully understood the study and voluntarily signed the informed consent form (ICF); Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (GC\u002FGEJ) adenocarcinoma with unresectable advanced or metastatic disease; HER2-negative and mismatch repair-proficient (pMMR); Moderate or greater volume of ascites at baseline; Peritoneal metastasis confirmed by ascites cytology or laparoscopy; Aged 18 to 75 years, regardless of sex; Receiving first-line anti-PD-1 immunotherapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel.\n\nExclusion Criteria:\n\n\\- History of or concurrent active malignancy other than gastric cancer within the past 5 years; Previous systemic treatment for unresectable advanced or metastatic GC\u002FGEJ adenocarcinoma.","ALL","18 Years","75 Years",{"count":84,"type":85},50,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the efficacy and safety of anti-PD-1 therapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment for patients with advanced gastric or gastroesophageal junction (GC\u002FGEJ) adenocarcinoma with malignant ascites. The study will also explore potential predictive biomarkers of treatment response through longitudinal collection and multi-omics analysis of tumor tissue, peripheral blood, and ascites.",[89,90,91],"Gastric Cancer Peritoneal Metastases","Gastric Cancer (GC)","Ascites, Malignant",[93,94,95],"Gastric Cancer","Peritoneal Metastases","Malignant ascites","2026-09-28",{"date":98,"type":99},"2026-10-02","ACTUAL",{"date":101,"type":99},"2026-07-01",{"date":103,"type":85},"2028-07-31",{"name":5,"class":6},1]