[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-carcinoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-carcinoma-metastatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100573252","phase-1-the-safety-and-efficacy-of-pressurized-intraperitoneal-aerosol-chemotherapy-for-peritoneal-metastatic-adenocarcinoma-100573252",false,"NCT06743867","The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma","A Prospective, Multi-center, Single-arm Clinical Research Evaluating the Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastatic Adenocarcinoma","Inclusion Criteria:\n\n1. Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;\n2. Applicable to individuals of either sex, aged between 18 and 75 years;\n3. Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;\n4. Absence of other concurrent malignancies;\n5. Without contraindications for laparoscopic surgery;\n6. Laboratory testing: blood routine examination: neutrophil count ≥ 1.5× 10\\^9\u002FL, platelet count ≥ 80 × 10\\^9\u002FL, hemoglobin ≥ 80g\u002FL ; blood biochemistry: serum total bilirubin ≤ 1.5 ×ULN, Alanine transaminase and aspartate aminotransferase ≤ 2.5 ×ULN, serum creatinine ≤ 1.5 ×ULN;\n7. Life expectancy \\> 6 months;\n8. Informed consent understood and signed.\n\nExclusion Criteria:\n\n1. Presenting symptoms of gastrointestinal obstruction;\n2. Fully reliant on parenteral nutrition;\n3. Exhibiting decompensated ascites;\n4. Suffering from severe abdominal infection (indications of peritonitis);\n5. Characterized by extensive adhesions in the abdominal cavity;\n6. Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures;\n7. With portal vein thrombosis;\n8. Concurrently, individuals with significant or unmanaged medical conditions or infections (including atrial fibrillation, angina, cardiac dysfunction, ejection fraction \\\u003C 50%, refractory hypertension etc.);\n9. Previous chemotherapeutic drugs allergy;\n10. Severe cardiopulmonary, hepatonephric, hematologic, and metal diseases, or drug abuse;\n11. Pregnancy or lactating women;\n12. Engage in additional clinical trials within three months preceding recruitment;\n13. Other conditions: patients are inappropriately included as determined by researchers.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This research is a prospective, multi-center, single-arm clinical trial aimed at assessing the standard pressurized intraperitoneal aerosol chemotherapy (PIPAC) utilizing a novel nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancer.\n\nThe primary objectives of this study are to assess the safety and efficacy of PIPAC with the novel NDDS in the treatment of PMA. Primary endpoints include adverse events (AEs) and serious AEs, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidences of device defects, postoperative pain scores evaluated using the Visual Analogue Scale \u002F Score (VAS), and quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). Secondary endpoints include the intra-abdominal peritoneal cancer index (PCI), peritoneal regression grading score (PRGS), objective response rate (including partial response (PR) and complete response (CR)), improvement in ascites, conversion rate (patients proceeding to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following initial PIPAC treatments), progression-free survival (PFS), and overall survival (OS).",[27],"Peritoneal Carcinoma Metastatic","RECRUITING","2024-12-19",{"date":31,"type":32},"2024-12-20","ACTUAL",{"date":34,"type":32},"2024-12-11",{"date":36,"type":21},"2026-09-30",{"name":38,"class":39},"Guangdong Provincial People's Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100415041","early-phase-1-dual-targeting-her2-and-pd-l1-car-t-for-solid-tumors-100415041","NCT04684459","Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors","Phase I Study of Specific CAR-T Dual-targeting HER2 and PD-L1 for HER2-positive Solid Tumors","Inclusion Criteria:\n\n1. Male or female, Age 18-75 years old; If the subjects are over 75 years old, the researchers will determine whether to enroll according to the basic health conditions of the subjects, regardless of gender. No upper age limit was set for chest\u002Fabdominal reinfusion CAR-T subjects.\n2. Estimated life expectancy ≥ 3 months (according to investigator's judgement);\n3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;\n4. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, pancreatic cancer, colorectal cancer, transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma, cholangiocarcinoma, etc. have received standard systemic treatment, have systemic metastasis\u002Fserosal cavity metastasis or are not tolerated;\n5. Expressing HER2 \\>20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);\n6. Absolute neutrophil count ≥ 1×10\\^9\u002FL, platelet count ≥ 75×10\\^9\u002FL, absolute lymphocyte count ≥0.5×10\\^8\u002FL, hemoglobin ≥ 8.0 g\u002Fdl;\n7. Creatinine clearance rate ≥60ml\u002Fmin, Serum ALT\u002FAST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;\n8. Cardiac ejection fraction ≥50%, no pericardial effusion;\n9. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);\n10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;\n11. Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or designated personnel;\n12. Voluntarily participate in the research, understand and sign the informed consent;\n13. The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.\n\nExclusion Criteria:\n\n1. Allergic to cytokines;\n2. Uncontrolled activity infection;\n3. Acute or chronic (graft-versus-host disease) GVHD;\n4. Accompanied by other uncontrolled malignant tumors;\n5. Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;\n6. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;\n7. Patients with grade 2-3 hypertension or poorly controlled;\n8. History of mental illness that is difficult to control;\n9. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;\n10. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug;\n11. Unstable pulmonary embolism, deep venous embolism or other major arterial\u002Fvenous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy;\n12. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends;\n13. Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements.",{"count":49,"type":21},18,[51],"EARLY_PHASE1","CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. In this study, the PD-L1 inhibitory signal was transformed into an activation signal in the tumor microenvironment, and enhanced the killing activity and survival ability of CAR-T cells. The HER-2\u002FPD-L1 dual-targeting CAR-T will be investigated in patients with HER2-positive solid tumors, and all enrolled subjects will receive HER2\u002FPD-L1 CAR T cells via intravenous or thoracic\u002Fperitoneal cavity infusion.",[27,54,55],"Pleural Effusion, Malignant","HER2 Positive Malignancies","2024-10-27",{"date":58,"type":32},"2024-10-30",{"date":60,"type":32},"2021-03-12",{"date":62,"type":21},"2025-12-30",{"name":64,"class":39},"Sichuan University"]