[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-pleural-effusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-pleural-effusion":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,76,97,130,152,182,202,233,253],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100424401","oncodrivers-in-malignant-pleural-effusions-associated-with-non-small-cell-lung-cancer-a-prospective-study-100424401",false,"NCT04806412","Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.","The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)\n* Patients must be able to give informed consent\n\nExclusion Criteria:\n\n* Full oncodriver status measured in any pleural fluid in current work-up\n* Inability to understand written or spoken Danish.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.",[26,27],"Malignant Pleural Effusion","Non-small Cell Lung Cancer","RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2021-03-15",{"date":36,"type":20},"2028-12-31",{"name":38,"class":39},"Naestved Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":40},"100627006","phase-1-fast-tils-to-treat-metastatic-pleural-effusions-from-epithelial-or-mesothelial-primary-tumors-100627006","NCT07443020","Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors","Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors: A Phase I Trial (FAST TILS 2)","RIOT 4B","Inclusion Criteria:\n\n1. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.\n2. Patients will be ≥ 18 and \\\u003C 80 years of age.\n3. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 12 months after ACT administration.\n\n   Male participants must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the preparative regimen.\n4. Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography.\n5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.\n6. ECOG Performance Status 0 or 1.\n7. Patients must have an expected survival \\> 12 weeks.\n8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.\n9. Patients must consent to collection of demographic and clinical data.\n\nExclusion Criteria:\n\n1. Infection with HIV and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.\n2. Infection with hepatitis B and active viral replication.\n3. Infection with hepatitis C and active viral replication.\n4. Patients currently being treated for bacterial, fungal or viral infection.\n5. Documented myocardial infarction within 6 months of study participation and\u002For symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.\n6. Investigational drug use within 30 days before effusion collection.\n7. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.\n8. Corticosteroid therapy \\> 10 mg of prednisone (biological equivalent) daily within 2 weeks before effusion collection.\n9. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.\n10. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:\n\n    AST\u002FSGOT \\> 2.0 times the upper limit of normal ALT\u002FSGPT \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\\>3.0 times the upper limit of normal) Hemoglobin \\\u003C 8 gm\u002FdL or dependent upon transfusion to maintain ≥ 8 gm\u002FdL White blood cell count \\\u003C 2,000\u002Fmm3 Platelet count \\\u003C 100,000\u002Fmm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \\> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL\u002Fmin.\n11. Pregnant or lactating females.\n12. Prior solid organ transplantation\n13. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.\n14. Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.\n15. Patients with documented anaphylaxis as a result of penicillin allergy.","79 Years",{"count":5,"type":20},[52],"PHASE1","This research study aims to evaluate the safety and effectiveness of a novel immunotherapy, Fast TIL, an Adoptive Cellular Therapeutic (ACT), to fight cancer that has spread to the pleura or pleural mesothelioma. The ACT product is created at AHN West Penn using the participant's pleural infiltrating T-cells (PIT). It is administered through a pleural catheter along with the drug Interleukin-2 (IL-2). Based on previous research it is believed that it may help fight the tumor and relieve symptoms.\n\nAs a participant, their pleural fluid will be collected and the PIT cells will be isolated and expanded in the lab to create the ACT product. Before receiving the ACT product through their pleural catheter, they will undergo outpatient lymphodepleting chemotherapy. LDC is a standard procedure for many approved immunotherapy treatments Following the infusion, they'll receive IL-2 through the catheter for two days to stimulate the expanded PIT cells.\n\nThe active treatment phase lasts about three weeks, with follow-up visits over five years at AHN West Penn Hospital, potentially requiring a hospital stay of up to six days. Blood samples will be taken to monitor their response. As this is a first-in-human study, treatment carries an unknown risk up to and including death from toxicity. However, the risks of similar immunotherapy treatments are well documented.",[26,55,56,57],"Malignant Mesothelioma","Pleural Effusion, Malignant","Metastasis to Pleura",[59,60,61,62,63,64,65,66],"metastasis to pleura","pleural infiltrating T cells","CliniMACS Prodigy","malignant mesothelioma","pleural effusion, malignant","Adoptive Cellular Therapeutic","immunotherapy","autologous tumor infiltrating lymphocytes (TIL)","2026-04-01",{"date":69,"type":32},"2026-04-07",{"date":71,"type":20},"2026-05",{"date":73,"type":20},"2038-03",{"name":75,"class":39},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":53,"conditions":86,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":40},"100607772","phase-1-fast-tils-to-treat-metastatic-cancer-patients-with-pleural-disease-100607772","NCT07192900","Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease","Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial","(RIOT 4A)","Inclusion Criteria:\n\n1. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.\n2. Patients will be ≥ 18 and \\\u003C 80 years of age.\n3. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 6 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.\n4. Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography.\n5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.\n6. Karnofsky performance score ≥ 70.\n7. Patients must have an expected survival \\> 12 weeks.\n8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.\n9. Patients must consent to collection of demographic and clinical data.\n\nExclusion Criteria:\n\n1. Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma.\n2. Infection with Human Immunodeficiency Virus (HIV) and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.\n3. Infection with hepatitis B and active viral replication.\n4. Infection with hepatitis C and active viral replication.\n5. Patients currently being treated for bacterial, fungal or viral infection.\n6. Documented myocardial infarction within 6 months of study participation and\u002For symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.\n7. Investigational drug use within 30 days before effusion collection.\n8. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.\n9. Corticosteroid therapy \\> 10 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection.\n10. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.\n11. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:\n\n    AST\u002FSGOT \\> 2.0 times the upper limit of normal ALT\u002FSGPT \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\\>3.0 times the upper limit of normal) Hemoglobin \\\u003C 8 gm\u002FdL or dependent upon transfusion to maintain ≥ 8 gm\u002FdL White blood cell count \\\u003C 2,000\u002Fmm3 Platelet count \\\u003C 100,000\u002Fmm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \\> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL\u002Fmin.\n12. Pregnant or lactating females.\n13. Prior solid organ transplantation\n14. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.\n15. Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.\n16. Patients with documented anaphylaxis as a result of penicillin allergy.",{"count":5,"type":20},[52],[26,55,56,57],[59,60,61,62,63,64,65,66],"2026-01-13",{"date":90,"type":32},"2026-01-15",{"date":92,"type":20},"2026-03",{"date":94,"type":20},"2037-12",{"name":96,"class":39},"David Bartlett, MD",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":106,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100486919","unc-pleural-fluid-registry-100486919","NCT05620329","UNC Pleural Fluid Registry","University of North Carolina Pleural Fluid Registry","Inclusion Criteria:\n\n* Patients who are 18 years or older\n* Inpatients and outpatients\n* Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:\n* pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion\n* malignancy\n\nExclusion Criteria:\n\n* A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.\n* Incarcerated individuals",{"count":105,"type":20},9999,"32 Years","OBSERVATIONAL","Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.",[110,111,112,26,113],"Lung Cancer","Lung Infection","Breast Cancer","Empyema",[115,116,117,118,119,120],"biospecimen","pleural fluid","lung cancer","cancer","infection","breast cancer","2025-10-15",{"date":123,"type":32},"2025-10-16",{"date":125,"type":32},"2018-01-24",{"date":127,"type":20},"2050-01-24",{"name":129,"class":39},"UNC Lineberger Comprehensive Cancer Center",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":40},"100604265","impact-of-patient-position-on-chemical-pleurodesis-by-chest-ultrasound-100604265","NCT07147270","Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound","Inclusion Criteria:\n\n* Patients who will be admitted at Chest department, Ain-Shams University Hospitals with malignant pleural effusions candidate for pleurodesis\n\nExclusion Criteria:\n\n* Multiloculated fluid\n* Previous failed pleurodesis\n* Liver failure\n* Renal failure\n* Congestive heart failure\n* Prolonged use of steroids or NSAIDs\n* Refusal to participate",{"count":137,"type":20},30,[23],"chemical pleurodesis using doxycycline is an acceptable and commonly employed palliation for malignant pleural effusion. Rotation of patient during pleurodesis using the powder from doxycycline capsule is still practiced in some centers. The benefit of rotation practice in pleurodesis can be verified after properly designed study on the outcome of pleurodesis with rotation and non-rotation by chest ultrasound assessment",[141,26,142],"Effect of Patient Rotation on Pleurodesis Success and Patient Comfort","Pleurodesis","2025-08-22",{"date":145,"type":32},"2025-08-29",{"date":147,"type":32},"2025-05-01",{"date":149,"type":20},"2026-02",{"name":151,"class":39},"Ain Shams University",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":40},"100517333","phase-1-tocilizumab-delivered-via-pleural-and-peritoneal-catheters-in-patients-with-advanced-metastatic-cancer-100517333","NCT06016179","Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer","Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer","RIOT2","Inclusion Criteria:\n\n1. Males or females ages 18-89 years\n2. Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.\n3. Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites\n4. Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement\n5. ECOG 0-2\n6. Able to read and understand consent in English and provide informed consent\n\nExclusion Criteria:\n\n1. Pediatric patients\n2. Laboratory abnormalities that indicate clinically significant inflammatory process AST\u002FSGOT \\> 2 times the upper limit of normal ALT\u002FSGPT \\> 2 times the upper limit of normal Total bilirubin \\> 2 times the upper limit of normal Creatinine \\> 2.5 mg\u002FdL Hemoglobin \\\u003C 7 mg\u002FdL White blood cell count \\\u003C 3,000\u002F mm3 Platelet count \\\u003C 70,000\u002Fmm3 Absolute neutrophil cell count \\\u003C 2,000 per mm3\n3. ECOG \\> 3\n4. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits\n5. Pregnant and lactating women\n6. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be \\>30 days prior to the first treatment visit\n7. Investigational drug use within 30 days prior to first treatment dose\n8. History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)\n9. Patient with known hypersensitivity to tocilizumab (IL-6)\n10. Active infection\n11. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine","89 Years",{"count":162,"type":20},12,[52],"The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.",[26,166],"Malignant Ascites",[26,166,168,169,170,171,172,173],"Tocilizumab","IL-6 receptor antagonist","peritoneal cavity","pleural cavity","intraperitoneal","intrapleural","2025-05-19",{"date":176,"type":32},"2025-05-22",{"date":178,"type":32},"2024-01-30",{"date":180,"type":20},"2027-01",{"name":75,"class":39},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100590200","effectiveness-of-intercostal-tube-drainage-vs-pigtail-catheter-drainage-vs-ultrasound-guided-aspiration-in-management-of-massive-malignant-pleural-effusion-100590200","NCT06964321","Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion","Inclusion Criteria:\n\n* Adult patient aged 18 years old and above.\n* Patients diagnosed with massive malignant pleural effusion (MPE) requiring intervention.\n\nExclusion Criteria:\n\n* Pediatric patients aged below 18 years\n* Patients with non-malignant causes of pleural effusion.",{"count":189,"type":20},66,[23],"Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells.\n\nIt is a common symptom and accompanying presentation of metastatic disease. It Impacts up to 15% of all patients with cancer and is the most common in breast, lung, cancer, lymphoma, and gynaecological malignancies . There are 150,000 new cases of MPE in the United States yearly and 100,000 in Europe . Patients have an overall survival (OS) rate of 3-12 months after the initial diagnosis . Malignant pleural effusion (MPE) poses significant challenges in management, impacting patient quality of life and overall prognosis. Almost all radiological procedures can help diagnose pleural effusions . Thoracentesis is used as a diagnostic and therapeutic tool. The procedure has been modified with the addition of ultrasound, that is very functional for targeting certain anatomical areas of the pleura and finding an appropriate entry point . Three primary strategies are commonly employed: intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration. This study aims to evaluate these methods' efficacy, safety, and outcomes. To compare intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).",[26],"NOT_YET_RECRUITING",{"date":195,"type":32},"2025-05-09",{"date":197,"type":20},"2025-06-01",{"date":199,"type":20},"2026-08-01",{"name":201,"class":39},"Assiut University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":219,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":40},"100571923","phase-1-a-study-of-mt027-in-patients-with-pleural-malignant-tumors-100571923","NCT06726564","A Study of MT027 in Patients with Pleural Malignant Tumors","A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors","Inclusion Criteria:\n\n1. voluntarily participate in the study and sign informed consent;\n2. age over 18 years old (including the cut-off value), regardless of gender;\n3. advanced malignant solid tumor pathologically and\u002For histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);\n4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;\n5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;\n6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and\u002For pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression;\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;\n8. within 7 days before treatment laboratory meet the following criteria:\n\nRoutine blood (14 days) :\n\n1. Absolute neutrophil count (ANC) ≥1.5×109 \u002FL;\n2. platelet count (PLT) or 80 x 109 \u002F L;\n3. hemoglobin (HGB) or 80 g\u002FL (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ;\n\nLiver:\n\n1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);\n2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;\n\nKidney:\n\n1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (estimated by Cockcroft-Gault formula);\n\n   Blood coagulation function:\n2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less;\n3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause.\n\nExclusion Criteria:\n\n1. known allergy to the study drug or its excipients;\n2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;\n3. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);\n4. in the first test within 2 weeks before treatment received radiotherapy.\n5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;\n6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.\n7. participated in other drug clinical trials within 4 weeks before screening;\n8. always had targeted B7 - H3 CAR - T cells treatment;\n9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases;\n10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs;\n11. patients with severe autoimmune diseases;\n12. recipients of previous allogeneic tissue\u002Fsolid organ transplantation;\n13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;\n14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody;\n15. subjects had severe neurocognitive impairment as judged by the investigator;\n16. pregnant or lactating women;\n17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.",{"count":210,"type":20},18,[52],"This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK\u002FPD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..\n\nSubjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.",[214,26,215,216,217,218],"Advanced Malignant Solid Tumor","Pleura Carcinoma","Pleural Mesothelioma","Pleural Malignant Mesothelioma","Pleural Metastases",[220,221,222],"advanced malignant solid tumors","metastatic or primary malignant tumors in the pleural cavity","malignant pleural effusion","2024-12-05",{"date":225,"type":32},"2024-12-10",{"date":227,"type":32},"2024-05-15",{"date":229,"type":20},"2029-02",{"name":231,"class":232},"Suzhou Maximum Bio-tech Co., Ltd.","INDUSTRY",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":193,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":40},"100569189","pleural-bleomycin-vs-mechanical-abrasion-in-malignant-pleural-effusion-100569189","NCT06691009","Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion","Effectiveness of Pleurodesis by Pleural Abrasion Using Medical Thoracoscopy Versus Bleomycin Via Pleural Catheter in Patients With Malignant Pleural Effusion","Inclusion Criteria:\n\n* Patients who are 18 years old or more.\n* patients with rapidly accumulating moderate \\& massive malignant pleural. effusion that need frequent aspiration to relieve dyspnea and affect quality of life of the patient.\n\nExclusion Criteria:\n\n* patients not fit for thoracoscoy.\n* patients with life expectency less than 1 month .\n* trapped lung (endobronchial lesion).\n* excessive pleural adhesios.\n* mild effusion not need frequent aspiration and not affect\n* quality of life .\n* patients with chest infection : pneumonia , empyema .\n* patients with performance status that doesn't expected to increase by 1","80 Years",{"count":242,"type":20},70,[23],"Comparision between pleurodesis by pleural abrasion using medical thoracoscopy and bleomycin instillation via indwelling pleural catheter. Evaluating the effectiveness of pleural abrasion using medical thoracoscopy in patients with malignant pleural effusion and evaluating the role of ROSE in diagnosis and management of malignant pleural effusion",[26],"2024-11-13",{"date":248,"type":32},"2024-11-15",{"date":225,"type":20},{"date":251,"type":20},"2029-10-10",{"name":201,"class":39},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":40},"100568569","feasibility-of-ambulatory-talc-pleurodesis-100568569","NCT06682936","Feasibility of Ambulatory Talc. Pleurodesis","Can Talc Pleurodesis for Malignant Pleural Effusion be Performed on an Ambulatory Basis","Inclusion Criteria:\n\n* Malignant pleural effusion\n* Life expectancy \\>30 days\n* WHO PS 1-2 (3 if due to dyspnoea)\n\nExclusion Criteria:\n\n* Previous failed pleurodesis (on affected side)\n* Known non-expansile lung",{"count":261,"type":20},15,[23],"Patients with malignant pleural disease often experience a significant symptom burden and a short life expectancy. The cornerstone of their treatment is relieving breathlessness by draining fluid from around the lungs and attempting to prevent further fluid build up. Inpatient chest drainage and talc pleurodesis remains the most successful method of stopping the fluid build up but this often requires an average hospital stay of four days. This can be an inappropriate length of time for this patient group. Our study would investigate whether this treatment could be provided on an outpatient, ambulatory basis and facilitate a greater quality of life.\n\nThe investigators would assess deliverability of the trial protocol and collect patient feedback to see if our patients consider it an acceptable and worthwhile intervention.",[26,265,266],"Malignancy","Palliative Care",[222,268,269],"malignancy","palliative care","2024-11-08",{"date":272,"type":32},"2024-11-12",{"date":274,"type":32},"2024-01-10",{"date":276,"type":20},"2025-02",{"name":278,"class":39},"David Rollins"]