[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-ascites\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-ascites":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,74,98,121,148,172,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641183","phase-1-tlr9-immunotherapy-for-peritoneal-carcinomatosis-100641183",false,"NCT07658196","TLR9 Immunotherapy for Peritoneal Carcinomatosis","TLR9 Immunotherapy for Peritoneal Carcinomatosis (TIPC) - Phase 1 Study of the Safety and Efficacy of ACM-CpG Intraperitoneal Injections for Treatment in Patients With Colorectal or Appendiceal Adenocarcinoma Peritoneal Metastases or Malignant Ascites","TIPC","Inclusion Criteria:\n\n* Patients eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Male or female patients age ≥ 18 years of age at the time of informed consent\n  2. Must be able to provide written informed consent, stating an understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements\n  3. Must have documented CRC or appendiceal adenocarcinoma peritoneal carcinomatosis or malignant ascites. Primary tumor may be intact and limited liver and\u002For lung disease is permitted\n  4. Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment\n  5. Must have a life expectancy of ≥ 12 weeks as estimated by the investigator\n  6. Must have an ECOG status of ≤ 2\n  7. Patients with acceptable laboratory values defined as:\n\n     * Estimated creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 60 mL\u002Fmin, not dialysis dependent\n     * Total bilirubin ≤ 1.5 mg\u002Fdl, unless elevated bilirubin is clearly related to Gilbert syndrome (and total bilirubin \\\u003C 6.0 mg\u002Fdl)\n     * Alanine aminotransferase (ALT) ≤ 3.5 x upper limit of normal (ULN)\n     * Aspartate aminotransferase (AST) ≤ 3.5 x ULN\n     * Absolute neutrophil count \\> 1.0 x 109\u002FL (must be independent of blood product administration)\n     * Platelet count \\> 100 x 109\u002FL (must be independent of blood product administration)\n     * Hemoglobin ≥ 8 g\u002FdL (must be independent of blood product administration)\n  8. Surgically sterile patients or patients of childbearing potential (CBP) who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug\n  9. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to administration of study drug\n\nExclusion Criteria:\n\n1. Has received prior TLR9 therapy\n2. Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment\n3. Has received an investigational agent within 28 days of the start of treatment\n4. Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1\n5. Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve\n6. Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs\n7. Has high volume liver or lung metastases, defined as \\> 50% replacement of the liver volume by metastatic disease or \\> 5 lung lesions greater than 1 cm in size\n8. Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage\n9. Ongoing or untreated intra-abdominal infection or bowel obstruction\n10. Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required)\n11. Receiving continuous systemic corticosteroid therapy (≥ 10 mg\u002Fday of prednisolone or equivalent)\n12. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n    * A history of newly diagnosed transmural myocardial infarction, cerebral infarction, or pulmonary embolism within 6 months, except those approved by the medical monitor\n    * A history of newly diagnosed deep vein thrombosis (DVT) within 3 months\n    * Left ventricular ejection fraction (LVEF) \\\u003C 50%\n    * QTc \\>480 msec\n13. Active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection\n14. Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas\n15. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results\n16. History of hypersensitivity to TLR9 agonists\n17. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites. The main questions it aims to answer are:\n\n• To determine the safety and maximum tolerated dose (MTD) or optimal biologic dose (OBD) of intraperitoneal injection(s) of ACM-CpG for inoperable peritoneal metastases or malignant ascites? Researchers will assign treatment levels using escalating doses of ACM-CpG Therapy.\n\nParticipants will:\n\n* Will receive at least one dose of ACM-CpG therapy on Day 1 of a 28-day treatment cycle.\n* May receive up to 2 additional injections if they have clinically stable or responsive disease.\n* Must visit the clinic on Days 1, 4, 7, 10, 14, 21, and 28 for checkups and tests.\n* Will have a CT scan or MRI performed every 8 weeks for 3 scans and then continue to receive scans every 12 weeks to monitor their disease.",[27,28,29,30],"Malignant Ascites","Colorectal Adenocarcinoma","Peritoneal (Metastatic) Cancer","Appendiceal Adenocarcinoma",[32,33,34,27,35,30,36],"Metastatic disease must be primarily located in the peritoneal cavity","ACM-CpG","TLR9","Peritoneal Carcinomatosis,","CRC","NOT_YET_RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2030-07",{"name":47,"class":48},"Brown University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100641237","early-phase-1-nk521-in-the-treatment-of-advanced-solid-tumors-100641237","NCT07657416","NK521 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients with pathologically confirmed relapsed\u002Frefractory advanced solid tumors, including hepatocellular carcinoma and ovarian cancer. Patients enrolled in the intraperitoneal perfusion group (Group B) must have malignant ascites with tumor cells identified in the ascitic fluid.\n* Patients with advanced solid tumors who have received ≥ 1 line of standard therapy.\n* At least one measurable lesion on CT or MRI per RECIST v1.1.\n* ECOG performance status 0-2.\n* Life expectancy ≥3 months.\n* Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily signed and provided written informed consent.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular\u002Fcerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; uncontrolled hypertension.\n* Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment.\n* Received cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications.\n* Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment.\n* Received systemic therapy with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease.\n* Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:\n\n  a. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN); b. HCV antibody positive.\n* Meeting any of the following laboratory criteria:a. Hematology: Absolute neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C75×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL.b. Hepatic function: ALT \\>3×ULN (≥5×ULN for liver metastasis); AST \\>3×ULN (≥5×ULN for liver metastasis); TBIL \\>1.5×ULN, or TBIL \\>2.5×ULN (3.0 mg\u002FdL) for subjects with Gilbert syndrome.c. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.","65 Years",{"count":58,"type":21},18,[60],"EARLY_PHASE1","Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites. Group A consists of patients with mild ascites, who will receive NK521 via intravenous infusion. Group B includes patients with moderate to severe ascites, who will be treated with investigator-selected systemic regimens combined with intraperitoneal perfusion of NK521.\n\nSystemic and local medications will be administered in accordance with the treatment regimens of respective groups, and the safety of the study drug will be monitored. Preliminary anti-tumor efficacy will be assessed using the RECIST 1.1 criteria at Week 6 after the first infusion of NK521. Catheter placement and ascites drainage will be performed 3 days prior to the first intraperitoneal perfusion of NK521. After the initial intraperitoneal perfusion treatment, the therapeutic effect on ascites will be evaluated per the WHO criteria for ascites assessment.",[63,64,27],"Hepatocellular Carcinoma (HCC)","Ovarian Cancer","2026-06-15",{"date":40,"type":41},{"date":68,"type":21},"2026-06",{"date":70,"type":21},"2028-07",{"name":72,"class":73},"Base Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":49},"100640827","phase-1-wsk-im02-in-advanced-solid-tumors-with-malignant-effusions-phase-i-100640827","NCT07615894","WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)","A Single-Arm, Open-Label, Prospective Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of WSK-IM02 in Patients With Advanced Solid Tumors Complicated by Malignant Pleural or Peritoneal Effusions","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years.\n2. Voluntarily sign informed consent form.\n3. Patients with histologically or cytologically confirmed advanced solid tumors.\n4. Histologically or cytologically confirmed malignant pleural\u002Fperitoneal effusion requiring drainage; or, in the absence of histologic\u002Fcytologic evidence, pleural effusion with clear imaging evidence of malignant pleural\u002Fperitoneal lesions on chest\u002Fabdominal CT and diagnosed as malignant pleural\u002Fperitoneal tumor in clinical practice.\n5. Have received standard systemic therapy and developed clinical symptoms of serous cavity metastasis.\n6. ECOG performance status: 0-2 points. Patients with ECOG 3 may be included if, in the investigator's judgment, removal of the effusion could improve the score to 2 or above.\n7. Life expectancy ≥3 months.\n8. Adequate major organ function.\n9. Able to tolerate thoracentesis\u002Fabdominocentesis and catheter placement, or already have a functional thoracic\u002Fabdominal drainage catheter in place, and agree to receive study drug treatment via this route.\n\nExclusion Criteria:\n\n1. Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.\n2. Received local intracavitary therapy for pleural\u002Fperitoneal effusion (excluding diagnostic or symptom-relieving puncture\u002Fdrainage) within 2 weeks prior to the first dose of study drug.\n3. Received extra-thoracic\u002Fextra-abdominal radiotherapy within 2 weeks prior to the first dose of study drug, or received radical radiotherapy to pleural\u002Fperitoneal or pulmonary\u002Fabdominal lesions within 8 weeks prior to enrollment (palliative radiotherapy to chest\u002Fabdomen is permitted).\n4. Underwent major thoracic or abdominal surgery within 4 weeks prior to the first dose of study drug and not fully recovered, or planned to undergo elective major surgery during the study period.\n5. Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment.\n6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment.\n7. Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection.\n8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy.\n9. Pregnant or breastfeeding women.\n10. Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment.\n11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled\u002Fintra-articular steroids are permitted).\n12. Require systemic corticosteroids or other immunosuppressants within 2 weeks prior to the first dose of study drug, and expected to require long-term use during the study.\n13. Have poorly controlled or severe cardiovascular disease.\n14. Have poorly controlled metabolic disease or complete\u002Fsevere gastrointestinal obstruction requiring intervention.\n15. Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin.\n16. Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency.\n17. Active local infection at the administration site.\n18. Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis\u002Fabdominocentesis or catheter placement.\n19. Have any other concurrent, serious, and\u002For uncontrolled medical condition.","75 Years",{"count":83,"type":21},9,[24],"This is a prospective, single-center, interventional, phase I, dose-escalation, single-arm study designed to evaluate the safety, tolerability, and preliminary efficacy of intrapleural\u002Fintraperitoneal infusion of WSK-IM02 in patients with advanced solid tumors complicated by malignant pleural or peritoneal effusions who have failed standard of care.",[87,88,27],"Advanced Solid Tumors","Malignant Pleural Effusions","2026-05-22",{"date":91,"type":41},"2026-05-29",{"date":93,"type":21},"2026-06-01",{"date":95,"type":21},"2029-06-30",{"name":97,"class":73},"WestVac Biopharma Co., Ltd.",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":49},"100630665","at-home-paracentesis-for-women-with-cancer-related-malignant-ascites-paracentesis-100630665","NCT07490626","At-Home Paracentesis for Women With Cancer-Related Malignant Ascites (Paracentesis)","A Pilot Study of At-Home Paracentesis for Women With Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)","Paracentesis","Inclusion Criteria:\n\n* Female aged ≥ 18 years\n* Has completed an initial clinic-based paracentesis procedure.\n* Confirmed diagnosis of cancer.\n* Symptoms related to ascites requiring procedure in the opinion of the investigator.\n* Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator.\n* If applicable, participant is able to safely hold anticoagulant therapy per institutional standards prior to the procedure in the opinion of the investigator.\n* For participants of child-bearing potential, participant is following standard of care guidelines for contraception.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Rapidly deteriorating condition or suspected bowel obstruction.\n* Large ventral hernias or prior complications from paracentesis.\n* Need for concurrent procedures requiring hospital resources.\n* Known lack of safe environment or inability to obtain sterile conditions at home.\n* Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example,\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.","FEMALE",{"count":108,"type":21},20,[110],"NA","The goal of this study is to evaluate the change in symptoms for women with cancer-related malignant ascites who complete an at-home paracentesis procedure.",[27],"2026-03-23",{"date":115,"type":41},"2026-03-27",{"date":117,"type":21},"2026-05",{"date":70,"type":21},{"name":120,"class":48},"University of Utah",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":146,"locationsCount":49},"100623529","phase-1-intraperitoneal-injection-of-liposomal-irinotecan-as-monotherapy-or-in-combination-with-recombinant-mutant-human-tumor-necrosis-factor-or-bevacizumab-for-the-treatment-of-malignant-ascites-following-failure-of-prior-standard-therapy-100623529","NCT07397819","Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy","Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy：A Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Aged ≥18 years old, gender unrestricted.\n* Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites cytology, or peritoneal metastases diagnosed clinically based on imaging findings and symptoms).\n* Moderate to large volume of peritoneal effusion, with failure of initial treatment or previous intraperitoneal therapy with conventional chemotherapeutic agents and\u002For biological response modifiers. Moderate volume of ascites is defined as: ①Ascites depth ≥3 cm confirmed by supine abdominal ultrasound; ② Presence of clinical symptoms (chest distress, dyspnea, abdominal distension and discomfort) judged by the investigator to be related to peritoneal effusion.\n* ECOG performance status score 0-2.\n* Expected survival time \\>3 months.\n* Essentially normal cardiopulmonary function.\n* Adequate organ function, with subjects required to meet the following laboratory parameters:\n\n  1. Peripheral blood count: WBC ≥4.0×10⁹\u002FL, PLT ≥80×10⁹\u002FL, Hb ≥90 g\u002FL.\n  2. Renal function: Serum creatinine ≤2×ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥40 ml\u002Fmin.\n  3. Hepatic function: Total bilirubin ≤1.5×ULN; or total bilirubin \\>ULN with direct bilirubin ≤ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (for patients with liver metastases, ALT or AST ≤5×ULN is acceptable).\n  4. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.\n* Thyroid stimulating hormone (TSH) ≤ULN. If TSH is abnormal, serum triiodothyronine (T3) and thyroxine (T4) levels, together with clinical manifestations, shall be evaluated comprehensively; subjects in non-acute active phase are eligible for enrollment.\n* For non-surgically sterilized subjects of childbearing potential or female subjects of childbearing potential: A medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment period and for 6 months after the end of study treatment. For non-surgically sterilized female subjects of childbearing potential, serum or urine HCG test must be negative within 7 days prior to enrollment, and they must be non-lactating. For male subjects whose partners are women of childbearing potential, effective contraceptive measures must be adopted during the trial and for 6 months after the last administration of the study drug.\n* Voluntarily participate in the study with good compliance, sign a written informed consent form, and be able to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n* History of hypersensitivity to tumor necrosis factor (TNF), its derivative drugs, bevacizumab or its analogs, irinotecan, or liposomal irinotecan.\n* Diagnosis of malignant diseases other than gastrointestinal tumors within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and\u002For radically resected carcinoma in situ).\n* Receipt of any other investigational drug treatment or participation in an interventional clinical trial within 7 days prior to the first dose; or receipt of anti-tumor therapy (including Chinese herbal medicines with anti-tumor indications) within 7 days prior to the first dose of the study drug.\n* Pregnant or lactating women; women of childbearing potential who are unwilling to take contraceptive measures during the study period; or men who are unwilling to use effective contraceptive measures during treatment and for 1 year thereafter.\n* Significant impairment of major organ function.\n* Patients with obvious bleeding tendency.\n* Clinically significant or uncontrolled cardiac diseases, including unstable angina pectoris, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association (NYHA) Class III\u002FIV congestive heart failure, and uncontrolled arrhythmias (subjects with pacemakers or atrial fibrillation with well-controlled heart rate are permitted).\n* Clinically significant ECG abnormalities or relevant medical history as judged by the investigator; screening QTcF interval \\> 480 ms. For subjects with intraventricular conduction block (QRS interval \\> 120 ms), JTc interval may be used instead of QTc interval (if JTc is used, it must be ≤ 340 ms).\n* Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical treatment; a history of hypertensive crisis or hypertensive encephalopathy.\n* Severe acute infection that is uncontrolled; current fever (\\> 38℃), purulent or chronic infection, or unhealed wounds.\n* Patients with radiologically confirmed loculated peritoneal effusion; definitely diagnosed peritoneal infection.\n* Active acute or chronic hepatitis B or C infection, with hepatitis B virus (HBV) DNA \\> 2000 IU\u002FmL or 10⁴ copies\u002FmL; hepatitis C virus (HCV) RNA \\> 10³ copies\u002FmL; concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibody. Subjects who have received nucleoside analog antiviral therapy and achieved viral load below the above thresholds are eligible for enrollment. A known history of human immunodeficiency virus (HIV) infection or confirmed positive HIV test results.\n* Evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding \\> 30 mL within 3 months, hematemesis, melena, hematochezia); hemoptysis (\\> 5 mL of fresh blood within 4 weeks); a history of hereditary or acquired bleeding disorders or coagulation dysfunction. Clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer).\n* A history of arterial or venous thrombotic disease within 6 weeks prior to enrollment.\n* A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or anticipated need for major surgery during the study treatment period.\n* Failure to achieve adequate recovery from toxicity and\u002For complications of major surgery prior to the start of treatment.\n* Pregnant or lactating women; or subjects who plan to conceive or give birth during the study period from screening visit to completion of safety follow-up visit (90 days after the last dose for male subjects).\n* Receipt of radiotherapy within 4 weeks prior to the first dose of study drug.\n* Radiotherapy-related toxicities in subjects must have fully resolved, without the need for corticosteroid therapy, and radiation pneumonitis must be definitely excluded. For palliative radiotherapy for non-central nervous system (CNS) diseases, a 2-week washout period is permitted.\n* Uncontrolled neurological or psychiatric diseases\u002Fdisorders with poor compliance, resulting in inability to cooperate or report treatment responses. Uncontrolled primary brain tumors or central nervous system metastases with obvious intracranial hypertension or neuropsychiatric symptoms.\n* Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this trial.",{"count":129,"type":21},48,[24,131],"PHASE2","This study is a prospective, multi-cohort Phase Ib\u002FII clinical trial, consisting of two stages as follows:\n\n1. Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent.\n2. Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.",[27],[135,136,137,27,138],"Liposomal Irinotecan","Recombinant Mutant Human Tumor Necrosis Factor","Bevacizumab","Intraperitoneal Injection","RECRUITING","2026-02-02",{"date":142,"type":41},"2026-02-09",{"date":144,"type":41},"2025-11-28",{"date":95,"type":21},{"name":147,"class":48},"Dong sheng Zhang",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":49},"100593557","phase-1-a-phase-i-study-of-sim0388-in-participants-with-malignant-ascites-100593557","NCT07007988","A Phase I Study of SIM0388 in Participants With Malignant Ascites.","An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of Intraperitoneal Perfusion With Docetaxel Polymeric Micelles for Injection in Patients With Malignant Ascites","SIM0388-101","Inclusion Criteria:\n\n* Voluntary participation and signature of informed consent form;.\n* ≥ 18 years of age, male or female.\n* Participants with histologically and\u002For cytologically confirmed advanced\u002Fmetastatic solid tumors;.\n* Failure of at least one line of standard systemic anti-tumor therapy, unsuitability for standard systemic therapy, or absence of standard systemic therapy options.\n* Moderate or greater ascites confirmed by ultrasonography\n* ECOG performance status of 0, 1or 2.\n* Life expectancy ≥ 3 months.\n* Adequate hematologic and organ function.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male subjects agree to use adequate contraception.\n\nExclusion Criteria:\n\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment\n* Prior history of intraperitoneal paclitaxel-based therapy.\n* Use of strong CYP3A4 inhibitors or inducers within 7 days before the first dose or anticipated use during the study.\n* Failure to recover from adverse events caused by prior interventions to ≤Grade 1\n* Complete intestinal obstruction within 30 days prior to the first dose.\n* Myocardial infarction within 6 months, current unstable angina, primary cardiomyopathy, cerebrovascular events, congestive heart failure, symptomatic coronary artery disease requiring medication, arrhythmia requiring medication, QTcF interval \\>470 ms, or uncontrolled hypertension.\n* Uncontrolled primary brain tumors or CNS metastases.\n* Active infection.\n* Known history of HIV infection.\n* Active hepatitis B or hepatitis C infection.\n* Hypersensitivity to any active or inactive ingredient of SIM0388.\n* Pregnant or lactating women.\n* Any condition (medical history, disease, treatment, or lab abnormality) that may interfere with study results, impede full participation, or deemed by the investigator to contradict the subject's best interests.",{"count":157,"type":21},50,[24],"Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for injection in patients with malignant ascites",[27],[27,162],"Solid tumor","2025-06-03",{"date":165,"type":41},"2025-06-06",{"date":167,"type":41},"2025-04-24",{"date":169,"type":21},"2027-12",{"name":171,"class":73},"Jiangsu Simcere Pharmaceutical Co., Ltd.",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":49},"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":182,"type":21},12,[24],"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.",[186,27],"Malignant Pleural Effusion",[186,27,188,189,190,191,192,193],"Tocilizumab","IL-6 receptor antagonist","peritoneal cavity","pleural cavity","intraperitoneal","intrapleural","2025-05-19",{"date":196,"type":41},"2025-05-22",{"date":198,"type":41},"2024-01-30",{"date":200,"type":21},"2027-01",{"name":202,"class":48},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100549427","phase-2-the-efficacy-of-bevacizumab-and-serplulimab-combined-with-recombinant-mutant-humantumor-necrosis-factorrmhtnf-nc-in-the-treatment-of-malignant-ascites-100549427","NCT06433869","The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites","Multi-arm, Phase II Clinical Study of Intraperitoneal Injection of Recombinant Human Tumor Necrosis Factor, Bevacizumab Monoclonal Antibody, and Serplulimab for the Treatment of Malignant Ascites Patients With Standard Therapy Failure","Inclusion Criteria:\n\n* Age ≥18 years old, gender unlimited;\n* Malignant ascites confirmed by histology or cytology as originating from digestive system tumors (malignant confirmed by ascites cytology or clinically diagnosed as peritoneal metastases by imaging and symptoms);\n* Patients with more than a moderate amount of abdominal fluid, who have failed initial treatment or have been treated with conventional chemotherapy drugs and\u002For biological response modulators intravenously. Moderate ascites is defined as:\n\n  * B ultrasound examination of ascites ≥3cm in lying position;\n  * Accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension and discomfort, which were judged by researchers to be related to abdominal fluid accumulation);\n* ECOG physical status is 0-2;\n* Expected survival time \\>3 months;\n* Cardiopulmonary function is basically normal;\n* For adequate organ function, subjects must meet the following laboratory criteria:\n\n  * Peripheral blood imaging: WBC≥4.0×109\u002FL, PLT≥80×109\u002FL, Hb≥90g\u002FL;\n  * Renal function: serum creatinine ≤2×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml\u002Fmin;\n  * Liver function: total bilirubin ≤1.5× upper limit of normal value (ULN); Or total bilirubin \\>ULN but direct bilirubin ≤ ULN; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);\n  * Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n* Thyroid stimulating hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels and clinical manifestations should be investigated, and comprehensive assessment of non-acute activity can be included;\n* Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period; Women of reproductive age who were not surgically sterilized had to be negative for serum or urine HCG within 7 days prior to study enrollment. And must be non-lactation period; For men whose partners are women of childbearing age, effective contraception should be used during the trial and within 6 months after the last administration of the study drug;\n* Voluntarily enrolled in this study, with good compliance, signed written informed consent, and able to cooperate with follow-up observation.\n\nExclusion Criteria:\n\n* History of allergy to tumor necrosis factor and its derivatives, bevacizumab analogues, and Serplulimab;\n* Malignant diseases other than digestive tract neoplasms were diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and\u002For carcinoma in situ after radical resection);\n* Received any other investigational drug therapy or participated in an interventional clinical investigator within 7 days prior to initial dosing; Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indication) within 7 days prior to the first use of the study drug;\n* Pregnant or lactating women, women of childbearing age who did not want to use contraception during the study period; Or the man is unwilling to use effective contraception during treatment and during the following 1 year;\n* Significant damage to the function of important organs;\n* Patients with obvious bleeding tendency;\n* Clinically significant or uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to first dosing, New York Heart Association Class III\u002FIV congestive heart failure, and uncontrolled arrhythmia (in subjects who are allowed to wear a pacemaker or have atrial fibrillation and have a well-controlled heart rate);\n* Presence of ECG changes or medical history that investigators consider clinically significant; Screening QTcF interval \\>480 ms, subjects with indoor block (QRS interval \\>120 ms) can use JTc interval instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤340 ms);\n* Uncontrolled hypertension, systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;\n* Severe acute infection that is not under control; The patient is having fever (\\> 38℃), or has suppurative and chronic infection, and the wound is prolonged and does not heal;\n* Patients with encapsulated abdominal effusion confirmed by imaging; A definite diagnosis of abdominal infection;\n* Persons infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA\\>2000IU\u002Fml or 104 copies \u002Fml; Hepatitis C virus (HCV) RNA\\> 103 copies \u002Fml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive. After nucleotide antiviral therapy, those who were lower than the above criteria could be included in the group. A known history of human immunodeficiency virus (HIV) infection or a confirmed positive immunotest result;\n* Patients with obvious evidence of bleeding tendency or history within 3 months prior to enrollment (hemorrhage \\>30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (\\>5 mL fresh blood within 4 weeks); People with a history of inherited or acquired bleeding or coagulation disorders. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; Arterial or venous thrombotic disease was present 6 weeks before enrollment;\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n* Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy;\n* Complications of toxicity and\u002For major surgery have not fully recovered before starting treatment;\n* Women who are pregnant or nursing, or who are expected to become pregnant or give birth during the study period from screening visits to completion of safety follow-up visits (male subjects to 90 days after the last dosing);\n* Radiotherapy was received within 4 weeks prior to the first administration of the study drug. Subjects must have fully recovered from radiation-related toxicities without the need for corticosteroid therapy, confirming the rule out of radiation pneumonia. For palliative radiotherapy for non-CNS disease, a 2-week washout period is allowed;\n* Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, unable to cooperate with and describe the response to treatment; Patients with uncontrolled primary brain tumor or central nervous metastases, with obvious cranial hypertension or neuropsychiatric symptoms;\n* There are other conditions that researchers consider inappropriate to participate in this experiment.",{"count":211,"type":21},60,[131],"1. More than half of peritoneal metastases are from digestive tract. Peritoneal metastasis has poor prognosis, poor treatment response and limited means.\n2. rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion.\n\n3, There is increasing evidence that PD-1\u002FPD-L1 inhibitors in combination with vascular endothelial growth factor receptor (VEGFR) inhibitors have a complementary mechanism of action: VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration, thus playing a synergistic role with ICIs. The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150. Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression. Therefore, this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC",[27],"2024-05-29",{"date":217,"type":41},"2024-05-30",{"date":219,"type":41},"2023-12-14",{"date":221,"type":21},"2026-12-31",{"name":223,"class":48},"Sun Yat-sen University",3]