[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-stomach-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-stomach-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100574421","phase-1-intraperitoneal-immune-checkpoint-inhibitors-and-zoledronic-acids-for-gastric-cancer-malignant-ascites-100574421",false,"NCT06759064","Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites","Efficacy and Safety of Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids in Gastric Cancer Malignant Ascites: a Phase I\u002FII Clinical Study (IPIZA)","IPIZA","Inclusion Criteria:\n\n* Gastric adenocarcinoma diagnosed pathologically;\n* Malignant ascites confirmed by ascites cytology;\n* Presence of ascites confirmed by CT with ascites graded as 2nd and 3rd degree (EASL guidelines and ICA consensus);\n* Those aged 18-75 years;\n* Patients who had not undergone local administration of drugs in the abdominal cavity and systemic immunotherapy within the previous 4 weeks;\n* Vital signs are stable, Karnofsky score (≥70), and expected survival time is \\>3 months;\n* Normal bone marrow haematopoietic function, blood routine: HGB ≥90g\u002FL, WBC ≥2.5×10\\^9\u002FL (NEU ≥1.5×10\\^9\u002FL), PLT ≥90×10\\^9\u002FL;\n* Normal coagulation function without bleeding tendency (International normalised ratio of prothrombinogen INR\\\u003C1.5);\n* Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST and ALT ≤2 times the upper limit of normal (ULN) (or ≤5 times the upper limit of normal (ULN) if the abnormalities are mainly due to tumour infiltration);\n* Renal function: Cr ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60mL\u002Fmin.\n\nExclusion Criteria:\n\n* Non-malignant ascites (e.g., portal hypertension ascites or infected ascites);\n* Presence of contraindications to immunotherapy (including long-term hormone use, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.);\n* Combination of other serious cardiopulmonary diseases that affect the treatment, etc;\n* Patients with extensive abdominal adhesions; encapsulated peritoneal fluid; history of intestinal obstruction; and malignant patients with extensive distant metastases in the terminal stage;\n* Women who are breastfeeding, pregnant, or preparing for pregnancy;\n* Patients with plasma albumin (ALB) \\\u003C30 g\u002FL and severe hypoproteinemia;\n* Patients with known hypersensitivity to components of the test drug or its analogues;\n* Patients with other severe, acute or chronic diseases that may interfere with the interpretation of the study results and who, in the judgement of the investigator, are unsuitable for participation in the clinical trial;\n* Patients with cognitive dysfunction, or poor treatment compliance as judged by the investigator;\n* Participants in other clinical trials within 4 weeks;\n* Combination of other malignancies;\n* Those who, in the opinion of the investigator, are not suitable for participation in the clinical trial.","ALL","18 Years","75 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitor combined with zoledronic acid for the treatment of malignant ascites in gastric cancer.\n\nThis study is a phase Ib\u002FII clinical study to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer, which consists of two phases, firstly, the phase Ib safety study, which adopts the '3+3' drug-escalation experimental design, and after determining the safe and tolerable dose, it will proceed to the second part of the phase II efficacy study. The Phase II study was designed by Simon's two-stage approach to evaluate the efficacy of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer.",[29,30],"Cancer of Stomach, Adenocarcinoma","Ascites, Malignant",[32,33,34,35,36],"gastric cancer","malignant ascites","Immune checkpoint inhibitors","zoledronic acid","intraperitoneal injection","RECRUITING","2025-11-15",{"date":40,"type":41},"2025-11-19","ACTUAL",{"date":43,"type":41},"2024-09-12",{"date":45,"type":22},"2026-09-01",{"name":47,"class":48},"Qilu Hospital of Shandong University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100459613","phase-3-perioperative-flot-vs-adjuvant-xelox-for-ca-stomach-100459613","NCT05264896","Perioperative FLOT vs Adjuvant XELOX for CA Stomach","Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study","Inclusion Criteria:\n\n1. Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and\u002For ≥N1, in the absence of distant metastasis\n2. Surgically resectable disease based on clinical staging\n3. No previous gastrectomy or chemotherapy\n4. Age 18 or above but less than 80, and\n5. ECOG ≤2\n6. Hemoglobin \\>\u002F= 8.0 g\u002FdL\n7. Neutrophils \\>\u002F= 1.500\u002Fµl\n8. Platelets ≥ 100.000\u002Fµl\n9. Creatinine clearance ≥ 50 ml\u002Fmin\n10. Serum albumin \\>25 g\u002FL\n\nExclusion criteria:\n\n1. Distant metastases, direct tumor invasion to organs not resectable by surgery\n2. Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel\n3. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA\n4. Peripheral polyneuropathy ≥ NCI grade II\n5. Severe liver dysfunction (i) ALT \\>3 x upper limit of normal, and\u002F or (ii) total bilirubin \\>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \\>\u002F= 3.0 x upper limit of normal)\n6. Pregnancy or lactation\n7. Malignant secondary disease, dated back \\\u003C5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma)\n8. Serious uncontrolled infection or cocomitant severe medical conditions",{"count":58,"type":22},110,[60],"PHASE3","This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.",[29],[64,65,66,67],"Gastric cancer","Cancer of esophagogastric junction","Chemotherapy","FLOT","2023-09-06",{"date":70,"type":41},"2023-09-07",{"date":72,"type":41},"2022-03-21",{"date":74,"type":22},"2027-12-31",{"name":76,"class":48},"Chinese University of Hong Kong"]