[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma-hcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma-hcc":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,159,0,25,[9,46,78,105,132,157,176,200,219,242,273,298,315,336,368,390,422,446,471,493,547,567,588,623,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613337","project-for-multi-omics-based-early-detection-of-hepatocellular-carcinoma-promethea-study-100613337",false,"NCT07265271","Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)","CENTINEL","Inclusion Criteria:\n\n* Adults aged 18 to 100 years.\n* A histologically confirmed diagnosis of hepatocellular carcinoma.\n* A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.\n* Healthy volunteers without known liver disease or malignancy.\n* Received standard diagnostic and staging procedures as per local guidelines\n* Availability of blood or other biospecimens.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Lack of or inability to provide informed consent\n* History of other active malignancies within the past 5 years\n* Previous liver transplantation\n* Severe systemic infection or inflammatory disease at the time of enrollment\n* Inadequate sample quality or quantity",true,"ALL","18 Years",{"count":21,"type":22},600,"ESTIMATED","OBSERVATIONAL","Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited.\n\nThis study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.",[26],"Hepatocellular Carcinoma (HCC)",[28,29,30,31,32],"HCC","Liver cancer","tsRNA","Liquid Biopsy","Early Detection","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2025-01-15",{"date":41,"type":22},"2028-06-18",{"name":43,"class":44},"City of Hope Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100645279","phase-2-utilize-imaging-to-assess-changes-in-hepatocellular-carcinoma-perfusion-as-potentiated-by-intra-arterial-nitroglycerin-100645279","NCT07682454","Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin","Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin","Inclusion Criteria:\n\n1. Participants must have radiographically documented, previously untreated LIRADS V liver lesions or biopsy-confirmed hepatocellular carcinoma (HCC), as determined by the ZSFG Liver Tumor Board.\n2. Lesions must be determined to be suitable for conventional trans-arterial chemoembolization (cTACE) based on multidisciplinary tumor board review.\n3. No prior locoregional therapy (e.g., TACE, Y-90) to the index lesion(s).\n4. Age ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky \\>70%)\n6. Demonstrates adequate organ function as defined below:\n\n   1. Absolute neutrophil count \\>=1,500\u002Fmicroliter (mcL).\n   2. Platelets ≥100,000\u002Fmicroliter (mcL).\n   3. Total bilirubin ≤ 3.0 milligrams per deciliter (mg\u002FdL), unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   4. Aspartate aminotransferase (AST) \u002F serum glutamic-oxaloacetic transaminase (SGOT) ≤3 X institutional upper limit of normal.\n   5. Alanine aminotransferase (ALT) \u002F serum glutamic-oxaloacetic transaminase (SGPT) ≤3 X institutional upper limit of normal\n   6. Creatinine ≤ 1.5 x within institutional upper limit of normal or\n   7. Creatinine clearance Glomerular filtration rate (GFR) \\>= 60 milliliters per minute (mL\u002Fmin)\u002F1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 milliliters per minute (mL\u002Fmin)\u002F1.73 m2.\n7. Liver function: Child-Pugh score must be no higher than B5.\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n10. The female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after study intervention.\n\nExclusion Criteria:\n\n1. Multifocal disease (i.e., presence of more than one HCC lesion).\n2. Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.\n3. Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).\n4. Is currently receiving any other therapeutic\u002Finvestigational agents.\n5. Has participated in a study of an investigational product and received study treatment or used an investigational device within 3 weeks of the first use of an investigational product.\n6. Co-morbid disease or concurrent illness (e.g., cardiovascular disease, portal vein thrombosis).\n7. Hypersensitivity to nitroglycerine or any of its excipients.\n8. Concomitant medications (contraindicated):\n\n   1. Concurrent use of prescription phosphodiesterase inhibitors (e.g., sildenafil)\n   2. Concurrent use of nitrate-containing medications.\n   3. Concurrent use of vasoactive chemotherapeutic agents, such as bevacizumab (Avastin).\n9. Recent anti-cancer therapies:\n\n   1. Systemic anticancer therapies within 3 weeks of the procedure.\n   2. Radiation therapy within 2 weeks.\n   3. Antibody-based therapy within 4 weeks.\n   4. Use of investigational agents or devices within 3 weeks of the index procedure.\n10. Unresolved toxicities from prior cancer therapy, unless ≤ Grade 1 (excluding alopecia).\n11. Currently receiving any other therapeutic or investigational agents during the study period.",{"count":54,"type":22},50,"INTERVENTIONAL",[57],"PHASE2","This is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin.",[26,60],"Liver Cancer, Adult",[62,63,64,65,66],"Parenchymal Blood Volume Imaging","Transarterial Chemoembolization","Intra-Arterial Nitroglycerin","Tumor Perfusion","TACE","NOT_YET_RECRUITING","2026-06-26",{"date":70,"type":37},"2026-07-02",{"date":72,"type":22},"2026-08-01",{"date":74,"type":22},"2030-02-01",{"name":76,"class":44},"University of California, San Francisco",2,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":55,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100645208","gpc3-targeted-petct-in-hepatocellular-carcinoma-100645208","NCT07677774","GPC3-Targeted PET\u002FCT in Hepatocellular Carcinoma","Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Adult patients (aged 18 years or older);\n* Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);\n* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n* Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;\n\nExclusion Criteria:\n\n* The inability or unwillingness of the research participant or legal representative to provide written informed consent.\n* Inability to complete PET\u002FCT imaging.","80 Years",{"count":87,"type":22},40,[89],"NA","The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET\u002FCT in patients with suspected or histologically\u002Fclinically confirmed hepatocellular carcinoma, and to compare with 18F-FDG PET\u002FCT.",[26,92,93],"Glypican-3","GPC3-targeted PET\u002FCT",[95,92,93,28,96],"Hepatocellular Carcinoma","PET\u002FCT","2026-06-25",{"date":36,"type":37},{"date":100,"type":37},"2026-05-01",{"date":102,"type":22},"2028-05-31",{"name":104,"class":44},"The First Affiliated Hospital of Xiamen University",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":55,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100615320","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-pumitamig-alone-or-in-combination-with-ipilimumab-in-participants-with-first-line-advanced-or-unresectable-hepatocellular-carcinoma-hcc-rosetta-hcc-206-100615320","NCT07291076","A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)","ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1\u002F2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)","Inclusion Criteria\n\n* Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have no prior systemic therapy for advanced\u002F unresectable HCC.\n* Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria\n\n* Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.\n* Participants must not have an organ transplant or autoimmune disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":113,"type":22},198,[115,57],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)",[26],[119,120,121,122],"First line HCC","Unresectable HCC","Ipilimumab","Pumitamig",{"date":68,"type":37},{"date":125,"type":37},"2026-03-16",{"date":127,"type":22},"2031-10-14",{"name":129,"class":130},"Bristol-Myers Squibb","INDUSTRY",64,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":23,"phases":4,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100645029","hcc-risk-and-monitoring-in-patients-with-type-2-diabetes-100645029","NCT07675187","HCC Risk and Monitoring in Patients With Type 2 Diabetes","Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosed with type 2 diabetes mellitus and clinically followed with regular outpatient visits.\n* FIB-4 index greater than 2.67 (calculated based on AST, ALT, and platelet count within the past 6 months).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* HBsAg positive.\n* Anti-HCV positive and HCV RNA positive (patients with anti-HCV positive but negative HCV RNA are still eligible).\n* Prior history of hepatobiliary malignancies.\n* Undergoing regular abdominal ultrasound screening more than once per year.\n* Established diagnosis of liver cirrhosis via abdominal ultrasound or clinical evaluation.\n* Diagnosed with or treated for any malignancy within the past 2 years.\n* Women of childbearing potential or pregnant women.\n* Thrombocytopenia secondary to hematologic disorders.\n* Known history of human immunodeficiency virus (HIV) infection.\n* Concomitant use of medications that may interfere with PIVKA-II assay results (e.g., warfarin, vitamin K).",{"count":140,"type":22},2400,"3 Years","Liver cancer is a significant malignancy in Taiwan. With the widespread implementation of antiviral therapies, hepatitis B and C-related liver cancer has gradually declined; however, metabolic dysfunction-associated liver cancer continues to increase, particularly among patients with type 2 diabetes mellitus (T2DM) who also present with significant liver fibrosis. Current clinical guidelines lack standardized recommendations for liver cancer screening in this specific population, and data from prospective randomized controlled trials remain scarce.This study is a prospective randomized controlled trial enrolling patients aged 18 years, diagnosed with T2DM, and with a FIB-4 \\> 2.67. Participants will be randomly assigned to either the surveillance group or the standard-care group. The surveillance group will undergo blood tests every 6 months to monitor liver function, AFP, and PIVKA-II, alongside the calculation of the GAAD score. The standard-care group will receive liver function tests every 6 months according to routine clinical practice. Abdominal ultrasound or computed tomography (CT) scans will be arranged by clinicians when clinically indicated. All participants will undergo abdominal ultrasound at baseline and at the end of the third year, with blood samples and clinical data collected periodically. The primary endpoint of this study is the tumor size at the time of liver cancer diagnosis. Secondary endpoints include liver cancer staging, number of liver cancer tumors, liver cancer incidence, the proportion of patients receiving curative treatment, and the degree of liver fibrosis as reflected by changes in FIB-4. This study expects to clarify the clinical benefits of a GAAD score-based surveillance strategy compared to standard care in T2DM patients with high FIB-4 scores, thereby providing evidence-based support for future liver cancer screening strategies and clinical guidelines.",[144,26],"Type 2 Diabetes (T2DM)",[146,147,148,149],"Type 2 Diabetes","Liver Cancer","Surveillance","Prospective Randomized Study","2026-06-23",{"date":34,"type":37},{"date":36,"type":22},{"date":154,"type":22},"2030-12-31",{"name":156,"class":44},"National Taiwan University Hospital",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":77},"100594469","psma-pet-for-the-staging-and-management-of-hepatocellular-carcinoma-100594469","NCT07019844","PSMA PET for the Staging and Management of Hepatocellular Carcinoma","Addition of F18-Piflufolastat PET\u002FCT to Cross-Sectional Imaging for the Staging and Management of Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Adult patients age \\>18 years from the VA medical system\n* Treatment-naïve patients with HCC with BCLC B or C disease\n\nExclusion Criteria:\n\n* Patients with renal dysfunction or contrast allergy that precludes contrast enhanced cross sectional imaging\n* Patients with presence of active primary malignancy other than HCC and non-melanoma skin cancer in the past 3 years",{"count":165,"type":22},90,"This prospective, single-center study evaluates the clinical utility of F18-Piflufolastat (PSMA) PET\u002FCT when added to conventional cross-sectional imaging for patients with suspected or confirmed hepatocellular carcinoma (HCC). The study aims to determine whether PSMA PET\u002FCT improves diagnostic accuracy for indeterminate liver lesions (LI-RADS 3 and 4), enhances staging precision in treatment-naïve patients, and provides more accurate assessment of treatment response in patients undergoing locoregional therapy (LRT). The goal is to assess how PSMA PET\u002FCT may impact clinical decision-making, staging, and management of HCC across multiple stages of disease.",[26],{"date":68,"type":37},{"date":170,"type":37},"2024-09-19",{"date":172,"type":22},"2028-09-30",{"name":174,"class":175},"VA Office of Research and Development","FED",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100643894","a-post-approval-study-to-evaluate-safety-and-effectiveness-of-multicompartmental-dosimetry-planning-100643894","NCT07669727","A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.","A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning","ADVANCE-MCD","Inclusion Criteria:\n\n* TheraSphere Microspheres treatment determined as the optimal therapy\n* Have unresectable solitary HCC\n* Treatment Naïve\n* ECOG 0 or 1\n* Adequate liver function\n* Adequate renal and marrow function\n* Negative pregnancy test and\u002For adequate contraception for the patient and his\u002Fher sexual partner\n\nExclusion Criteria:\n\n* Macrovascular invasion\n* Extrahepatic metastases\n* Previous or current ascites\u002Fencephalopathy\n* Previous liver radiation, TACE, or systemic therapy for the disease\n* History of organ allograft including bone marrow\n* Any significant comorbities or contraindications to TheraSphere",{"count":185,"type":22},140,"The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.\n\nTheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into \"compartments\" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.\n\nTraditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses",[26],[95,189,190,191],"TheraSphere","multicompartment dosimetry","Radioembolization","2026-06-22",{"date":97,"type":37},{"date":195,"type":22},"2026-08",{"date":197,"type":22},"2029-05",{"name":199,"class":130},"Boston Scientific Corporation",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":55,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100644006","phase-2-a-study-evaluating-the-safety-and-efficacy-of-selective-internal-radiation-therapy-sirt-using-sir-spheres-y-90-resin-microspheres-to-bridge-or-downstage-patients-with-hepatocellular-carcinoma-hcc-to-liver-transplant-or-resection-and-elicit-pathologic-necrosis-100644006","NCT07663487","A Study Evaluating the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres to Bridge or Downstage Patients With Hepatocellular Carcinoma (HCC) to Liver Transplant or Resection and Elicit Pathologic Necrosis.","A Prospective, Multicenter, Open-label Two Cohort Study Evaluating the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres to Bridge or Downstage Patients With Hepatocellular Carcinoma (HCC) to Liver Transplant or Resection and Elicit Pathologic Necrosis.","Subjects must meet all of the following criteria to be eligible for study participation (Inclusion Criteria):\n\n1. Willing, able, and mentally competent to provide written informed consent\n2. Age 18 years or older at the time of informed consent\n3. All tumors must be measurable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to localized mRECIST\n4. Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 5 or by histology that is amenable to treatment with Y-90 radioembolization by radiation segmentectomy\n5. Patients must be treatment-naïve or have developed a new lesion following one of the prior locoregional treatments listed below, including TACE failure, as defined by the investigator:\n\n   1. Liver resection with negative pathologic margins, no vascular invasion, and no recurrence at resection margins for at least 6 months post-treatment and no new lesions within 6 months of liver resection\n   2. Ablation of a single ≤3 cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment\n   3. Trans-arterial chemoembolization (TACE) failure or refractoriness (e.g., inadequate response or progression following TACE), per investigator assessment\n6. Inclusion into the Bridging or Downstaging Cohort:\n\n   * Bridging Cohort:\n\n     * Unresectable HCC within Milan criteria for liver transplant at baseline (Mazzafero et al, 1996) \\[17\\]\n     * Solitary tumor ≤5 cm or up to 3 lesions each ≤3 cm\n     * No EHD\n     * No vascular involvement\n   * Downstaging Cohort:\n\n     * Unresectable HCC within UNOS downstaging criteria for liver transplant at baseline (Natarajan et al, 2023) \\[21\\]\n     * Solitary HCC 5-8 cm, or 2-3 tumors each ≤5 cm w\u002Fsum ≤8 cm or 4- 5 tumors each ≤3 cm w\u002Fsum ≤8 cm\n     * No Extrahepatic Disease (EHD)\n     * No vascular involvement\n7. Child-Pugh score of A5, A6, or B7 at baseline\n8. Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline\n9. Adequate blood count, liver enzymes, and renal function at baseline:\n\n   1. No absolute contraindications to arterial access\n   2. Albumin-bilirubin grade 1 or 2\n   3. International Normalized Ratio (INR) ≤2.0\n   4. Glomerular filtration Rate (GFR) \\>45\n   5. Negative serum pregnancy test at baseline\n\nSubjects must not meet any of the following exclusion criteria:\n\n1. Eligible for curative treatment by resection or not considered optimal candidates for curative ablation, in the opinion of the investigator, based on tumor location, multifocality, underlying liver disease, anticipated risk of recurrence, or institutional practice patterns.\n2. Prior systemic anti-cancer therapy (including immunotherapy and\u002For targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC\n3. Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)\n4. History of biliary-enteric anastomosis (e.g., hepaticojejunostomy) or active biliary infection (e.g., ongoing cholangitis) at the time of screening. Subjects with prior biliary intervention (e.g., Endoscopic Retrograde Cholangiopancreatography (ERCP), sphincterotomy, biliary stent placement) or suspected compromise of the Ampulla of Vater may be enrolled at the Investigator's discretion provided there is no evidence of active biliary infection and prophylactic antibiotic coverage is administered per institutional standard of care before and after Y-90 radioembolization.\n5. Planned localized cancer treatment to the liver, other than the study treatment, throughout the duration of the study\n6. Planned systemic cancer treatment throughout the duration of the study\n7. Portal vein tumor thrombosis (macrovascular invasion). Bland (non-tumoral) portal vein thrombosis is allowed if portal venous flow is preserved and there is no evidence of clinically significant portal hypertension complications that would increase risk of hepatic decompensation.\n8. Patients with EHD\n9. Patients with contraindications to angiography or selective visceral catheterization\n10. Evidence of extrahepatic collateral supply to the tumor\n11. Evidence of potential delivery of mean radiation dose \\>30 Gy to the lungs (single treatment)\n12. Evidence of any detectable 99mTc-MAA scintigraphy or cone-beam computed tomographic (CB-CT) evidence of any deposition outside of the liver in the gastrointestinal tract after application of established angiographic techniques to stop or mitigate such flow (e.g., placing catheter distal to gastric vessels or coiling)\n13. 99mTc-MAA hepatic arterial perfusion scintigraphy showing poor tumor and\u002For portal vein thrombosis targeting that would lead to a dose that does not meet the liver dosing criteria.\n14. Prior liver resection is permitted, provided the patient meets all other criteria and has recurrent HCC eligible for transplant consideration. Prior liver transplant remains exclusionary.\n15. Female patients who are pregnant, breastfeeding, or pre-menopausal and unwilling to use an effective method of contraception through the 1-year followup; males unwilling to use an effective method of contraception for 30 days post-procedure\n16. Evidence of portal hypertension with uncontrolled or refractory ascites despite optimal medical management or any active or uncontrolled variceal bleeding at the time of screening\n17. Concurrently enrolled in another study unless it is an observational, noninterventional study\n18. History of other cancer requiring active treatment within the past 3 years, with the exception of adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, in the opinion of the investigator.\n19. Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator\n20. Inability to safely receive contrast, narcotics, or sedatives required to complete treatment\n21. Any condition that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or the interpretation of study results\n22. Alpha-fetoprotein (AFP) \\>10000 ng\u002FmL at baseline",{"count":208,"type":22},78,[57],"This clinical investigation involves the use of an approved medical device (SIR-Spheres®) for a new purpose in patients with certain types of liver cancer. The goal is to determine whether this treatment can help patients qualify for or maintain eligibility for a liver transplant. Participation is completely voluntary and will not affect your standard medical care. The main risks involve possible side effects related to the use of radiation in the liver, such as fatigue, abdominal pain, nausea, or changes in liver function. You may or may not benefit personally from participating in this study, but the results may help improve future treatment for others.\n\nYour doctor is inviting you to take part in this clinical investigation because you have been diagnosed with liver cancer. Your doctors will have decided that treatments designed to remove or destroy cancer completely, such as surgery or heat treatment, are not suitable for you.\n\nThis clinical investigation is focused on testing how well selective internal radiation therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres (\"SIR-Spheres\") work, its potential benefits, its safety, and finding out if there are any bad effects when it's used like it's supposed to be used. For more information, please see the section on the purpose of the clinical investigation.\n\nThis Patient Informed Consent Form (PIC) tells you about the clinical investigation. It explains the tests and treatments involved and how your information will be used. Knowing what is involved will help you decide if you want to take part in the clinical investigation.",[26],{"date":97,"type":37},{"date":214,"type":22},"2026-10",{"date":216,"type":22},"2029-10",{"name":218,"class":130},"Sirtex Medical",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100643884","ultrasound-assessment-of-diaphragmatic-structure-and-function-in-patients-with-liver-cirrhosis-a-point-of-care-tool-for-predicting-complications-and-sarcopenia-in-limited-resource-settings-100643884","NCT07667608","Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.\n3. Ability to provide written informed consent in Arabic or English.\n4. For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.\n5. For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.\n6. For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL\u002FAASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.\n\nExclusion Criteria:\n\n1. Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1\u002FFVC \\\u003C70% with FEV1 \\\u003C60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.\n2. Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.\n3. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.\n4. Active mechanical ventilation at time of enrollment.\n5. Pregnancy.\n6. Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).\n7. Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).\n8. Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.\n9. Refusal or inability to provide informed consent.",{"count":226,"type":22},120,"The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are:\n\nDo patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?\n\nDoes removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?\n\nCan ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?\n\nParticipants will:\n\nUndergo diaphragmatic ultrasound during quiet and deep breathing\n\nProvide clinical and laboratory data related to liver disease severity\n\nIn some cases, have ultrasound repeated before and after paracentesis\n\nFor patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass",[229,230,231,26,232,233],"Cirrhosis of the Liver","Ascites","Pleural Effusion Disorder","Sarcopenia","Diaphragm Movement","2026-06-19",{"date":97,"type":37},{"date":237,"type":22},"2026-08-10",{"date":239,"type":22},"2027-12-10",{"name":241,"class":44},"Assiut University",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":55,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":251,"type":22},1314,[115],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[255,256,257,258,26,259,260,261,262,263],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Solid Tumor","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":192,"type":37},{"date":267,"type":37},"2021-12-14",{"date":269,"type":22},"2030-06-28",{"name":271,"class":130},"Exelixis",122,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":55,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100641290","phase-1-a-phase-1-and-2-study-of-vmd-102-in-hepatocellular-carcinoma-and-other-solid-tumors-100641290","NCT07636785","A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","SPKTAHC","Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and\u002For metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g\u002FdL (SI Units: 90 g\u002FL) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000\u002Fmm3 (60 x109\u002FL) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (1.5x109\u002FL) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\\u003C30% of the TBIL)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and\u002For ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL\u002Fmin using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g\u002Fd\u002FL.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and\u002For tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs\u002Fsymptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU\u002FmL. Participants on active HBV therapy with viral loads \\\u003C100 IU\u002FmL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue\u002Forgan transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and\u002For substances abuse, Phosphatidylethanol (Peth) must be \\\u003C50 ng\u002FmL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","75 Years",{"count":283,"type":22},111,[115,57],"This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver\u002FHCC tumor models and preclinical toxicology and pharmacology studies support this study.",[26,287,255,288,260],"Metastatic Uveal Melanoma","Nonsmall Cell Lung Cancer","2026-06-16",{"date":291,"type":37},"2026-06-18",{"date":293,"type":22},"2026-06",{"date":295,"type":22},"2031-12",{"name":297,"class":130},"VM Discovery, Inc.",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":313,"locationsCount":45},"100642013","tace-andor-haic-combined-with-molecular-targeted-therapy-and-immunotherapy-for-hcc-100642013","NCT07658833","TACE and\u002For HAIC Combined With Molecular-targeted Therapy and Immunotherapy for HCC","Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and\u002For HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma","Inclusion Criteria:\n\n* aged 18-80 years\n* Eastern Cooperative Oncology Group (ECOG) performance status score \\\u003C 2\n* maximum tumor diameter ≥ 7 cm\n* IVC\u002FRA TT diagnosed by contrast-enhanced CT \u002F MRI before study treatment\n* unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team\n* liver function of Child-Pugh class A or B\n\nExclusion Criteria:\n\n* with other malignancies\n* prior anti-tumor therapy\n* history of drug allergy\n* autoimmune diseases\n* digestive hemorrhage of any grade\n* insufficient renal, bone marrow, or coagulation function",{"count":226,"type":22},"The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and\u002For hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and\u002For HAIC combined with targeted immunotherapy for hepatocellular carcinoma.\n\nWe are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.",[26],"2026-06-15",{"date":192,"type":37},{"date":36,"type":22},{"date":312,"type":22},"2028-06-30",{"name":314,"class":44},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":55,"phases":324,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":334,"locationsCount":45},"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":323,"type":22},18,[325],"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.",[26,328,329],"Ovarian Cancer","Malignant Ascites",{"date":291,"type":37},{"date":293,"type":22},{"date":333,"type":22},"2028-07",{"name":335,"class":130},"Base Therapeutics (Shanghai) Co., Ltd.",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":18,"minAge":343,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":55,"phases":346,"briefSummary":347,"conditions":348,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":367},"100564996","phase-1-a-phase-i-first-in-human-study-of-cba-1205-anti-dlk1-monoclonal-antibody-in-patients-with-advanced-solid-tumors-hepatocellular-carcinoma-hcc-melanoma-and-pediatric-cancer-100564996","NCT06636435","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.","Inclusion Criteria:(Part 1-4)\n\n* Patients who provide voluntary written informed consent to participate in the study\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)\n* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500\u002FμL, Platelet count; ≥75000\u002FμL, Hemoglobin;≥9.0 g\u002FdL.\n* Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)\n* Patients with Child-Pugh A or B (Part2, 3)\n* Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)\n\nInclusion Criteria:(Part 5)\n\n* Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives\n* Japanese patients aged 2 years or older and under 20 years at the time of informed consent\n* Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL\u002Fmin\u002F1.73 m²)\n* Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy\n\nExclusion criteria: (Part1-5)\n\n* Patients who have undergone major surgery within 28 days before enrollment\n* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and\u002For drug therapy within 14 days before enrollment\n* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment\n* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity\n* Patients who have received any other investigational product within 28 days before enrollment\n* Patients with current or previous inadequately controlled or clinically significant cardiac disease\n* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate","2 Years",{"count":345,"type":22},66,[115],"In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.",[349,26,350,351],"Solid Tumors","Malignant Melanoma","Pediatric Cancer",[353,354,355,356,357,95,358,359,351],"DLK1","First in human","Phase I","Antibody","solid tumor","CBA-1205","Melanoma",{"date":264,"type":37},{"date":362,"type":37},"2020-06-01",{"date":364,"type":22},"2027-06-30",{"name":366,"class":130},"Chiome Bioscience Inc.",5,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":375,"targetDuration":4,"studyType":55,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":386,"leadSponsor":388,"locationsCount":4},"100642842","phase-2-pd-1il-2-bispecific-antibody-as-neoadjuvant-therapy-for-early-recurrent-hepatocellular-carcinoma-after-curative-hepatectomy-100642842","NCT07644208","PD-1\u002FIL-2 Bispecific Antibody as Neoadjuvant Therapy for Early Recurrent Hepatocellular Carcinoma After Curative Hepatectomy","A Phase II Study to Evaluate the Efficacy and Safety of PD-1\u002FIL-2 Bispecific Antibody as Neoadjuvant Therapy in Hepatocellular Carcinoma Patients With Early Recurrence After Curative Hepatectomy and Eligible for Re-resection","Inclusion criteria:\n\n1. Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.\n2. Aged between 18 and 75 years old (inclusive), with no restriction on gender.\n3. Diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or meeting the clinical diagnostic criteria for HCC formulated by the American Association for the Study of Liver Diseases (AASLD) or the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.\n4. Must provide tumor tissue specimens obtained from the initial surgical resection during the screening period.\n5. Have a history of curative hepatectomy for HCC, with pathologically confirmed tumor recurrence occurring 3 months to 2 years after surgery. Candidates shall be assessed by a multidisciplinary team (MDT) and meet all the following criteria for repeat resection:\n\n   CNLC stage Ia-Ib or IIa-IIb, with recurrent lesions confined to one hepatic lobe; Adequate liver function reserve with Child-Pugh Class A; The volume of the future liver remnant (FLR) accounts for ≥40% of the standard liver volume (SLV) in patients with chronic liver disease, liver parenchymal damage or liver cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis; No vascular tumor thrombus; No extrahepatic metastasis.\n6. Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), and the lesion has not received any local therapy.\n7. Have adequate organ and bone marrow function. Laboratory test results obtained within 7 days prior to enrollment shall meet the following requirements. No blood products, erythropoietin, colony-stimulating factors, thrombopoietin, albumin or other parenteral corrective medications are allowed within 14 days before laboratory testing:\n\n   Hematology: Hemoglobin (HGB) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL; Platelet (PLT) count ≥ 100×10⁹\u002FL.\n\n   Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN). Participants with TBIL \\> 1.5 × ULN but conjugated bilirubin ≤ ULN are also eligible; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 5 × ULN; Alkaline Phosphatase (ALP) ≤ 4 × ULN; Serum albumin ≥ 30 g\u002FL.\n\n   Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula using actual body weight). Urinalysis shows urine protein \\\u003C 2+. For participants with urine protein ≥ 2+ at baseline, the 24-hour urinary protein quantification shall be \\\u003C 1 g.\n\n   Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN; Partial Thromboplastin Time (PTT) \u002F Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN. Participants on stable-dose anticoagulant therapy shall remain within the expected therapeutic range of the prescribed anticoagulants.\n8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n9. Expected survival time of no less than 6 months.\n10. Female participants of childbearing potential and male participants whose partners are of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last study drug administration.\n\nExclusion criteria:\n\n1. Histologically or cytologically confirmed diagnosis of tumors containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed carcinoma, and intrahepatic cholangiocarcinoma.\n2. Prior treatment with anti-PD-1\u002FPD-L1 agents or other antitumor immunotherapies.\n3. Presence of unresolved Grade \\>1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, anemia, peripheral neuropathy, electrolyte abnormalities manageable with treatment, and endocrine disorders well-controlled with hormone replacement therapy are excluded).\n4. History of hepatic encephalopathy or seizures; presence of active, newly diagnosed or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis or leptomeningeal metastases.\n5. Presence of clinically significant cardiovascular and cerebrovascular diseases, including:\n\n   * Severe conduction disorders (e.g., third-degree atrioventricular block);\n   * Symptomatic, clinically unstable arrhythmias or arrhythmias requiring clinical intervention;\n   * Corrected QT interval (QTc, calculated via Fridericia's formula) ≥ 480 ms;\n   * Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>90 mmHg despite optimal medical treatment), or history of hypertensive crisis or hypertensive encephalopathy;\n   * History of myocarditis;\n   * Symptomatic congestive heart failure (New York Heart Association Class II-IV) or left ventricular ejection fraction (LVEF) \\\u003C 50% on cardiac ultrasonography;\n   * Any arterial thrombosis, embolism or ischemic event within 6 months prior to the first study drug administration, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack;\n   * History of deep vein thrombosis, pulmonary embolism or other severe thromboembolic events within 6 months before enrollment (Thrombosis related to implantable venous access ports, catheters or superficial phlebitis is not defined as severe thromboembolism). Patients with adequately treated deep vein thrombosis may be enrolled if deemed stable by the investigator.\n6. Current or prior history of interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, severe pulmonary dysfunction or other restrictive lung diseases requiring corticosteroids or other treatments.\n7. History of severe or uncontrolled allergic diathesis, drug allergy, asthma or atopic dermatitis.\n8. Known allergy to IL-2, sintilimab, other monoclonal antibodies or their excipients.\n9. Symptomatic pleural effusion, ascites or pericardial effusion requiring repeated drainage (Patients with effusions not requiring drainage or with no obvious reaccumulation within 3 days after drainage discontinuation are eligible for enrollment).\n10. History of active autoimmune diseases requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years prior to the first drug administration. Replacement therapies (e.g., levothyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are not regarded as systemic treatment.\n11. History of allogeneic organ transplantation (including liver transplantation) or allogeneic hematopoietic stem cell transplantation.\n12. Active uncontrolled bleeding, known bleeding diathesis, unhealed severe wounds, ulcers or fractures; history of esophagogastric variceal bleeding caused by portal hypertension within the preceding 6 months. Grade 3 varices confirmed by endoscopy within 3 months before the first administration. Patients with evidence of portal hypertension (including splenomegaly on imaging) with high bleeding risk assessed by investigators shall undergo endoscopic evaluation.\n13. Presence of major gastrointestinal diseases within 6 months prior to or at the time of drug administration, including gastrointestinal perforation, severe gastrointestinal fistula (with severely impaired gastrointestinal function or requiring invasive intervention), history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n14. Confirmed HIV positivity or history of acquired immunodeficiency syndrome (AIDS); active hepatitis B or hepatitis C (HCV), or history of infection with the above viruses.\n\n    * For patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), HBV DNA testing is required. Those with HBV DNA ≤ 10⁴ copies\u002FmL, ≤ 2000 IU\u002FmL or below the lower limit of quantification are eligible. HBsAg-positive patients must receive antiviral therapy throughout the study with regular HBV DNA monitoring.\n    * Patients with positive HCV serology but undetectable HCV RNA are permitted to enroll.\n    * Patients who have completed anti-HCV treatment with undetectable viral load are eligible for enrollment.\n15. Active tuberculosis, patients currently receiving anti-tuberculosis treatment or those who received anti-tuberculosis therapy within 1 year before the first drug administration; patients with active syphilis requiring treatment.\n16. Severe, active or uncontrolled infections, infections requiring intravenous systemic antibiotics, or unexplained fever (\\>38 °C) within 2 weeks prior to the first study drug administration.\n17. Diagnosis of other pathologically confirmed malignant tumors within 5 years before enrollment. Exceptions include radically cured basal cell carcinoma, squamous cell carcinoma of the skin, completely resected carcinoma in situ, radically resected local prostate cancer and papillary thyroid carcinoma, as well as other malignancies with complete remission, no evidence of active disease for at least 2 years prior to enrollment and extremely low recurrence risk.\n18. Excluded medications and treatments (None of the following interventions are allowed):\n\n    a Last dose of antitumor therapies administered within 4 weeks before the first study drug: systemic chemotherapy (2-week washout period for oral fluoropyrimidines), endocrine therapy, targeted therapy (washout period of 2 weeks or 5 half-lives, whichever is longer), immunotherapy and tumor embolization. Traditional Chinese medicines for antitumor indications or immunomodulatory drugs (e.g., thymosin, interferon, interleukin) last administered within 1 week prior to the first dose.\n\n    b. Participation in any medical device or other interventional clinical trials within 2 weeks before the first dose or during the study period.\n\n    c. Palliative radiotherapy administered within 2 weeks before the first dose. d. Live vaccines for infectious disease prophylaxis administered within 4 weeks before the first dose.\n\n    e. Immunosuppressants or systemic corticosteroids (equivalent to \\>10 mg prednisone per day) administered within 2 weeks before the first dose.\n\n    f. Major surgery performed within 4 weeks before the first dose.\n19. Pregnant or breastfeeding females, or females planning to become pregnant before drug administration, during treatment or within 6 months after the last dose of study drug.\n20. Any concomitant disease, prior treatment, abnormal laboratory findings, history of substance abuse or current substance use, which in the investigator's judgment may compromise patient safety, hinder informed consent acquisition, affect treatment compliance or interfere with the safety assessment of the study drug.",{"count":376,"type":22},30,[57],"This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1\u002FIL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection.\n\nA total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1\u002FIL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1\u002FIL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery.\n\nThe primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy.\n\nThis study intends to explore the clinical value of PD-1\u002FIL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.",[26],[95,381],"Neoadjuvant Therapy","2026-06-08",{"date":384,"type":37},"2026-06-12",{"date":308,"type":22},{"date":387,"type":22},"2029-04-01",{"name":389,"class":44},"Shanghai Zhongshan Hospital",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":400,"conditions":401,"keywords":405,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":45},"100575902","msept9-biomarker-for-predicting-hepatocellular-carcinoma-occurrence-in-patients-with-cirrhosis-100575902","NCT06778317","mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis","Evaluation of the Circulating Epigenetic Biomarker mSEPT9 for Predicting the Occurrence of Hepatocellular Carcinoma in Patients With Cirrhosis: A Prospective Multicenter Trial (SEPT9_SuRV)","SEPT9_SuRV","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients diagnosed with cirrhosis confirmed by clinical, biochemical, radiological, or histological criteria.\n* Cirrhosis attributable to one or more of the following etiologies: alcohol, hepatitis C (HCV), hepatitis B (HBV), nonalcoholic steatohepatitis (NASH), hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or cryptogenic causes.\n* Patients actively followed in one of the participating study centers.\n* Patients affiliated with a social security program or equivalent.\n* Patients with a body weight greater than 45 kg.\n* Patients who have been fully informed about the study procedures and have provided oral informed consent.\n\nExclusion Criteria:\n\n* History of hepatocellular carcinoma (HCC).\n* History of any other primary or secondary malignant liver tumor.\n* Diagnosis of malignancy or hematologic disorders within the past 5 years (without time limitation for hematologic malignancies).\n* Patients currently undergoing hemodialysis.\n* Pregnant or breastfeeding women.\n* Individuals under legal protection (e.g., guardianship, curatorship) or unable to provide consent.\n* Minors or individuals younger than 18 years.\n* Individuals deprived of liberty by judicial or administrative order.\n* Patients with psychiatric conditions receiving care under legal constraints (e.g., articles L.3212-1 and L.3213-1).\n* Patients unable to comply with the study protocol requirements.",{"count":399,"type":22},400,"This study aims to evaluate the role of the circulating epigenetic biomarker mSEPT9 in predicting the risk of hepatocellular carcinoma (HCC) in patients with cirrhosis. HCC is a primary liver cancer that frequently develops in individuals with cirrhosis, and early detection is critical for improving outcomes. This research involves 400 patients with cirrhosis who will be followed every six months for up to 60 months. During these visits, blood samples will be collected to analyze mSEPT9 levels. By identifying changes in this biomarker, the study seeks to improve early diagnosis and personalize surveillance strategies, potentially enhancing patient survival and quality of life.",[26,402,403,404],"Cirrhosis","Risk Prediction for Liver Cancer","Epigenomics",[95,402,406,407,408,409,410,411,412,404,413],"mSEPT9 Biomarker","Epigenetics","Risk Prediction","Liver Cancer Surveillance","Prospective Cohort Study","Non-Invasive Biomarkers","Personalized Medicine","Risk Stratification",{"date":415,"type":37},"2026-06-10",{"date":417,"type":37},"2025-06-03",{"date":419,"type":22},"2033-06-03",{"name":421,"class":44},"Central Hospital, Nancy, France",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":430,"conditions":431,"keywords":436,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":45},"100625066","construction-and-clinical-validation-of-a-predictive-model-for-postoperative-adjuvant-therapy-in-hepatocellular-carcinoma-based-on-whole-slide-digital-pathological-images-and-deep-learning-100625066","NCT07417800","Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning","Inclusion Criteria:\n\n* Histopathologically confirmed hepatocellular carcinoma;\n* Aged more than 18 years;\n* Underwent radical resection of primary liver cancer (R0 resection);\n* Availability of postoperative H\\&E-stained paraffin embedded tissue sections suitable for digital whole-slide imaging;\n* Had complete and accessible clinicopathological data and follow-up data;\n* Has complete and evaluable preoperative and postoperative contrast-enhanced CT or MRI imaging with standardized scanning parameters and no severe artifacts, meeting the quality requirements for radiomic and artificial intelligence analysis.\n\nExclusion Criteria:\n\n* Significant missing clinical or follow-up data;\n* Concurrent primary malignancy in other organs;\n* Positive surgical margin (R1 or R2 resection);\n* Tissue sections of poor quality (e.g., severe fading, folding, damage) unsuitable for digital scanning or analysis;",{"count":429,"type":22},11000,"Hepatocellular carcinoma (HCC) is a high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources.\n\nTumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence.\n\nThis study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT\u002FMRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies.\n\nThis is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients will be prospectively and consecutively enrolled from 10-15 centers. The AI model will generate adjuvant therapy predictions without interfering with real clinical decisions. Patients will be divided into prediction-consistent and prediction-inconsistent cohorts based on the match between model predictions and actual treatments. Long-term follow-up will be performed to compare prognostic outcomes and validate the model's real-world performance and stability.\n\nKey inclusion criteria: histopathologically confirmed HCC; aged 18-75 years; received R0 curative resection; available qualified H\\&E-stained FFPE slides for digital scanning; complete clinical, pathological and follow-up data; high-quality preoperative contrast-enhanced CT\u002FMRI images eligible for AI analysis. Key exclusion criteria: prior preoperative anti-tumor therapy with unavailable baseline data; concurrent other primary malignancies; non-R0 resection; unqualified pathological slides or imaging data; severe missing clinical or follow-up information.",[26,432,433,66,434,435],"Artificial Intelligent","Adjuvant Chemoradiotherapy","Lenvatinib","Liver Surgery",[26,432,66,437,433],"lenvatinib","2026-06-07",{"date":415,"type":37},{"date":441,"type":37},"2025-11-01",{"date":443,"type":22},"2029-12-01",{"name":445,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":453,"targetDuration":4,"studyType":55,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":467,"leadSponsor":469,"locationsCount":45},"100643572","phase-2-lenalidomide-plus-targeted-therapy-and-immunotherapy-for-refractory-hcc-100643572","NCT07639138","Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC","Safety and Efficacy of Lenalidomide Combined With Targeted Therapy and Immunotherapy in Patients With Advanced Hepatocellular Carcinoma Resistant to Multiple Prior Lines of Treatment: A Single-Center, Single-Arm, Prospective Exploratory Study","Inclusion Criteria:\n\n-1. Age ≥18 years and ≤75 years; 2. Clinically or pathologically diagnosed hepatocellular carcinoma (HCC); 3. Unresectable, locally advanced, or metastatic HCC; 4. Prior receipt of at least two lines of systemic antitumor therapy, with previous exposure to both targeted therapy and immune checkpoint inhibitors (ICIs). No restrictions are imposed on the specific targeted agents or ICIs used in combination with lenalidomide; 5. Demonstrated clinical benefit from the most recent line of dual-agent therapy, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 4 weeks, followed by radiographic progression or clinical treatment failure; 6. At least one measurable lesion according to RECIST version 1.1; 7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1; 8. Adequate organ function, defined as: absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL, platelet count ≥60 × 10\\^9\u002FL, hemoglobin ≥80 g\u002FL, creatinine clearance (CrCl) ≥30 mL\u002Fmin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × upper limit of normal (ULN), and total bilirubin ≤3 mg\u002FdL; 9. Virological status, including hepatitis B virus (HBV) and hepatitis C virus (HCV), must be assessed. Patients who are HBsAg-positive or have a history of HBV infection must undergo hepatology evaluation and receive antiviral prophylaxis when indicated.\n\nExclusion Criteria:\n\n* 1\\. Primary resistance to the most recent targeted therapy plus ICI regimen, defined as unequivocal disease progression within 6 weeks or 2 treatment cycles without any evidence of prior clinical benefit; 2. Prior exposure to lenalidomide or a history of severe hypersensitivity to lenalidomide or thalidomide; 3. Explosive disease progression, or situations in which continuation of the existing treatment backbone is deemed clinically unreasonable by the investigator; 4. Uncontrolled ascites, hepatic encephalopathy, or active gastrointestinal bleeding; active severe infections, including uncontrolled HBV replication, tuberculosis, severe pulmonary infection, or other serious infections; 5. Persistent treatment-related toxicities of grade ≥2 that have not recovered to baseline or acceptable levels at study entry; 6. Creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin; 7. Pregnancy, breastfeeding, or inability\u002Funwillingness to comply with contraceptive requirements.",{"count":454,"type":22},32,[57],"This is a prospective, single-arm, investigator-initiated clinical study designed to evaluate the safety and efficacy of lenalidomide in combination with targeted therapy and immunotherapy in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after multiple lines of systemic treatment.\n\nEligible patients must have received at least two prior lines of systemic therapy, including both targeted therapy and immune checkpoint inhibitor (ICI)-based treatment, and must have previously achieved clinical benefit from their most recent treatment regimen before developing disease progression.\n\nParticipants will continue their current targeted therapy and immunotherapy regimen and receive lenalidomide as add-on treatment. The study will assess antitumor activity, survival outcomes, and treatment-related adverse events.\n\nThe primary objectives are to evaluate 6-month progression-free survival (PFS) and the incidence of grade ≥3 treatment-related adverse events (TRAEs). Secondary objectives include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and overall survival (OS).",[26],[459,460,461,462,463],"Advanced Hepatocellular Carcinoma","Multiline-Refractory HCC","Lenalidomide","Targeted Therapy","Immunotherapy","2026-06-05",{"date":415,"type":37},{"date":415,"type":22},{"date":468,"type":22},"2030-06-30",{"name":470,"class":44},"Shunda Du",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":55,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":367},"100625223","phase-1-a-phase-1-study-of-the-safety-and-tolerability-of-ctx-10726-100625223","NCT07419841","A Phase 1 Study of the Safety and Tolerability of CTX-10726","A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed\u002Frefractory to standard therapy or for which no effective standard therapy is available, including:\n\n2a: Renal Cell Carcinoma (RCC)\n\n* Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.\n* Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)\u002F programmed cell death ligand 1 (PDL1) treatment.\n* Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).\n* Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible.\n\n  2b: Hepatocellular Carcinoma (HCC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab.\n* Hepatic function: Child -Pugh A and Child-Pugh B7.\n* Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed.\n\n  2c. Gastroesophageal Cancer (GC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patients must have received prior treatment with platinum-based chemotherapy.\n\n  2d: Endometrial Cancer (EC)\n* Patients must have received at least 1 cycle of platinum-based chemotherapy.\n* Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy.\n* Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n\n  3\\. Patients must have measurable disease per RECIST 1.1. Tumor sites that are considered measurable must not have received prior radiation.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\n  5\\. Adequate organ function including:\n* Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion).\n* Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\\\u003C3 x ULN in patients with Gilbert's syndrome), AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases).\n* Renal function defined as creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft Gault equation.\n* Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n\n  6\\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment.\n\n  7\\. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-10726.\n\n  8\\. Prior anticancer therapy \\> 28 days (or 2 half-lives for proteins, whichever is shorter), radiotherapy \\> 7 days (concurrent localized palliative radiotherapy is allowed during CTX-10726 treatment with medical monitor approval), therapeutic surgical intervention \\> 21 days, blood transfusion \\> 14 days, or biopsy or minor surgery (excluding placement of vascular access devices) \\> 7 days prior to the first dose of CTX-10726.\n\n  9\\. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2 (excluding alopecia).\n\n  10\\. Capable of understanding and complying with protocol requirements\n\n  11\\. Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.\n2. Prior organ transplantation.\n3. History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.\n4. History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.\n5. Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for \\>4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n6. A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.\n7. Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.\n8. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.\n9. A history of significant bleeding tendency or severe coagulopathy.\n10. Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg\u002Fday) is allowed.\n11. Current or recent use of aspirin (\\> 325 mg\u002Fday) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.\n12. Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.\n13. The presence of poorly controlled hypertension (systolic blood pressure \\[SBP\\]\u002Fdiastolic blood pressure \\[DBP\\]) \\>140\u002F90 mmHg (eg, patient with SBP\u002FDBP \\> 140\u002F90 mmHg despite ≥3 anti-hypertensive medications within 7 days of dosing with CTX-10726).\n14. Pregnant or lactating WOCBP.\n15. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and\u002For detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n\n    1. Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \\\u003C 1000 copies \u002Fml (200 IU\u002Fml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required.\n    2. HIV-infected subjects who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection.\n16. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection).\n17. Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period.\n18. Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement (≤ 10 mg\u002Fday prednisone or equivalent) for patients with adrenal insufficiency are allowed.\n19. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor.\n20. Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, severe respiratory distress, pulmonary insufficiency or continuous oxygenation.\n21. Other medical conditions in the opinion of the Investigator and\u002For Sponsor Medical Monitor may interfere with the conduct and\u002For interpretation of the current study, including:\n\n    1. Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias.\n    2. QTc interval (using Fridericia correction calculation) \\> 480 msec.",{"count":479,"type":22},70,[115],"This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.",[483,26,484,255],"Gastroesophageal Cancer (GC)","Endometrial Cancer","2026-06-04",{"date":464,"type":37},{"date":488,"type":37},"2026-05-28",{"date":490,"type":22},"2028-11-01",{"name":492,"class":130},"Compass Therapeutics",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":501,"targetDuration":141,"studyType":23,"phases":4,"briefSummary":503,"conditions":504,"keywords":516,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":543,"leadSponsor":544,"locationsCount":546},"100642988","registry-of-minimally-invasive-cancer-treatment-using-spectral-angio-ct-image-guidance-100642988","NCT07636148","Registry of Minimally Invasive Cancer Treatment Using Spectral Angio-CT Image Guidance","Prospective Registry of Spectral Angio-CT-Guided Interventional Oncology Procedures in Routine Clinical Practice","PreciseOnco","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Undergoing a clinically indicated IO procedure with a percutaneous or transarterial approach for solid tumors;\n* Use of spectral angio-CT image guidance as part of standard care;\n* Written confirmed consent.\n\nExclusion Criteria:\n\n* Patients who are declared incapacitated;\n* Patients suffering from psychic disorders that make a comprehensive judgement impossible.",{"count":502,"type":22},2000,"This study collects data from patients undergoing minimally invasive, image-guided cancer treatments at participating hospitals in the Netherlands and France. All treatments are performed as standard clinical care and include procedures such as tumor ablation and catheter-based treatments of cancer in the liver, kidney, lung, and bone.\n\nDuring these procedures, a spectral angio-CT system is used for image guidance. This advanced CT scanner automatically captures additional imaging information beyond what is used in routine clinical decision-making. The goal of this study is to investigate how this additional imaging information is associated with treatment outcomes, and how it can be used in the future to improve treatment planning, procedural guidance, and prediction of treatment results.\n\nNo experimental interventions are performed. Participation does not alter the treatment or follow-up patients receive. Data are collected from medical records and imaging systems and stored securely for analysis.",[505,506,507,508,509,510,26,511,255,512,513,514,515],"Liver Cancer (Primary and Metastatic)","Lung Cancer (Diagnosis)","Bone Cancer Metastatic","Bone Cancer Tumor","Kidney Tumors","Renal Cancer","Renal Cell Carcinoma (Kidney Cancer)","Musculoskeletal Cancers","Musculoskeletal Tumors","Bone Tumors","Lung Tumors",[517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538],"Spectral CT","Dual-layer detector CT","Angio-CT","Image-guided therapy","Interventional oncology","Thermal ablation","Radiofrequency ablation","Microwave ablation","Cryoablation","Transarterial chemoembolization","Transarterial radioembolization","Transarterial embolization","Local tumor control","Tumor recurrence","Progression-free survival","Hepatocellular carcinoma","Liver metastases","Renal cell carcinoma","Lung tumors","Musculoskeletal tumors","Registry","Multicenter","2026-06-03",{"date":541,"type":37},"2026-06-09",{"date":36,"type":22},{"date":154,"type":22},{"name":545,"class":44},"Mark C Burgmans, MD PhD",3,{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":555,"targetDuration":141,"studyType":23,"phases":4,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":45},"100401706","liver-cancer-registry-platform-100401706","NCT04510740","Liver Cancer Registry Platform","JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer","JADE","Inclusion criteria:\n\n* Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced\u002Fmetastatic stage\n* Age ≥ 18 years\n* Signed and dated informed consent (IC):\n\n  * For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment\n  * For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment\n\nExclusion criteria:\n\nPatients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)",{"count":556,"type":22},1000,"The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.",[26,559],"Cholangiocarcinoma",{"date":485,"type":37},{"date":562,"type":37},"2020-08-09",{"date":564,"type":22},"2027-12",{"name":566,"class":130},"iOMEDICO AG",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":4},"100640838","liver-transplant-for-hepatocellular-carcinoma-100640838","NCT07629193","Liver Transplant for Hepatocellular Carcinoma","TH-CHC","Inclusion Criteria\n\n1. Adults (≥18 years).\n2. Underwent LT for HCC between January 1, 2018 and December 31, 2023.\n\nExclusion Criteria\n\n1. No evidence of HCC (imaging or histology).\n2. LT performed for another intrahepatic tumor other than HCC.\n3. The patient's objection to the use of their data.",{"count":575,"type":22},562,"This research focuses on analysing data collected as part of your usual care. Currently, the eligibility of patients with hepatocellular carcinoma for liver transplantation is based on the calculation of scores. These scores mainly take into account the volume of the tumour measured by imaging, one or more blood markers and the patient's general condition.\n\nHowever, these scores do not take into account:\n\n* the concept of downstaging (i.e. the prior reduction of tumour volume through locoregional or systemic treatments, which subsequently allows access to LT), which is becoming increasingly widespread\n* the dynamics of hepatocellular carcinoma (tumour recurrence while waiting on the transplant list, administration of wait-and-see treatments)\n* certain anatomopathological parameters (such as the macro-trabecular subtype of HCC).\n\nThe aim of our study is to develop a new score incorporating these factors in order to identify patients with hepatocellular carcinoma who could truly benefit from a liver transplant.\n\nTo answer the question posed in the research, data will be collected from 402 people who received a liver transplant for hepatocellular carcinoma at three hospitals in the Paris region between 1 January 2018 and 31 December 2023, and from 160 people at two international hospitals in Canada and Belgium.",[26,578],"Liver Transplantation (LT)",[580,578],"predictive score","2026-06-01",{"date":464,"type":37},{"date":293,"type":22},{"date":585,"type":22},"2027-01",{"name":587,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":594,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":55,"phases":597,"briefSummary":598,"conditions":599,"keywords":603,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100608130","phase-1-a-phase-11b-study-of-st-01156-a-small-molecule-rbm39-degrader-in-patients-with-advanced-solid-malignancies-100608130","NCT07197554","A Phase 1\u002F1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.\n* Has a metastatic or locally advanced and unresectable solid tumor.\n* Has at least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* Has an ECOG performance status ≤ 2 at screening.\n* Has adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Has received prior radiotherapy within 2 weeks of treatment.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.\n* Had major surgery within 28 days before study therapy administration\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.\n* Has previously received a RBM39 inhibitor\u002Fdegrader.","16 Years",{"count":596,"type":22},171,[115],"A Phase 1\u002F1B Study of ST-01156 in Patients with Advanced Solid Malignancies",[600,601,26,602],"Advanced Solid Tumors","Ewing Sarcoma","Biliary Tract Cancer (BTC)",[604,605,606,607,608,609,532,28,610,611,612],"cancer","solid tumors","RBM39","RBM39 degrader","metastatic solid malignancies","Ewing sarcoma","Biliary tract carcinoma","endometrial carcinoma","Adolescents","2026-05-30",{"date":615,"type":37},"2026-06-02",{"date":617,"type":37},"2025-12-01",{"date":619,"type":22},"2029-12-31",{"name":621,"class":130},"SEED Therapeutics, Inc.",6,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":55,"phases":631,"briefSummary":633,"conditions":634,"keywords":641,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":4},"100639971","phase-3-long-term-extension-study-for-participants-previously-enrolled-in-an-exelixis-sponsored-study-100639971","NCT07620574","Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study","Key Inclusion Criteria:\n\n* Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation\u002Fwithdrawal criteria).\n* Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator.\n* Able to comply with the long-term extension study protocol as determined by the investigator.\n* Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study.\n\nKey Exclusion Criteria:\n\n* Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.\n* Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant.\n* Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study.\n* Permanent discontinuation of all study treatment(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study (if applicable).\n* Concurrent participation in any therapeutic clinical trial (other than the parent study).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":630,"type":22},5000,[632],"PHASE3","The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.",[635,255,636,637,26,638,263,639,640],"Cancer","Pancreatic Neuroendocrine Tumors (pNET)","Extra-Pancreatic NET (epNET)","Differentiated Thyroid Cancer (DTC)","Colorectal Cancer","Prostate Cancer",[255,636,637,26,638,263,639],"2026-05-27",{"date":615,"type":37},{"date":645,"type":22},"2026-05-31",{"date":647,"type":22},"2030-05-31",{"name":271,"class":130},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":55,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":671},"100639637","improving-the-use-of-immunotherapy-to-treat-liver-cancer-100639637","NCT07623265","Improving the Use of Immunotherapy to Treat Liver Cancer","Optimizing and Improving Immunotherapy for Hepatocellular Carcinoma: the IO-MARC Study","IO-MARC","* General inclusion Criteria:\n\n  1. Male or female, age \\> 18 years\n  2. Diagnosis or suspected diagnosis of hepatocellular carcinoma based on imaging\n* Specific inclusion criteria cohort 1 (retrospective\u002Fprospective data may be applicable):\n\n  1. Pathologically confirmed HCC\n  2. Treated with systemic treatment \\[tyrosine kinase inhibitor (TKI) or immunotherapy (ICI)\\] in the last 7 years and follow-up data (at least one imaging on treatment) available until 01\u002F01\u002F2025\n  3. Biopsy obtained between 01\u002F01\u002F2018 until 01\u002F01\u002F2025\n  4. Left-over tissue from previous diagnostic biopsies or resection specimens available\n  5. Time between biopsy and initiation of systemic treatment \\\u003C 1 year\n  6. Ability to sign informed consent for secondary use of archival tissue and data collection for study-specific research for patients who are alive\n* Specific inclusion criteria cohort 2 (aHCC \\& prospective):\n\n  1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)\n  2. Indication for tumor biopsy per standard of care\n  3. Eligible for systemic treatment (any) after pathological confirmation of HCC\n  4. Ability to sign informed consent for primary use of tissue and blood samples and data collection for study-specific research\n* Specific inclusion criteria cohort 3 (eHCC \\& prospective):\n\n  1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)\n  2. Indication for local treatment (resection or ablation)\n  3. Ability to sign informed consent for primary use of tissue and blood samples and for data collection for study-specific research\n\n     Due to the observational nature of this study, participation in other (interventional) clinical trials is permitted, if biological materials can be collected per protocol.\n* General exclusion criteria:\n\n  1. Poor liver function and\u002For performance status which prohibits active treatment\n  2. Pathologically proven other malignancies of the liver, including primary cholangiocarcinoma or liver metastases\n  3. Treatment plan other than systemic treatment or local treatment (resection or ablation), such as TACE, TARE, liver transplantation",{"count":658,"type":22},300,[89],"This project targets patients with a form of primary liver cancer, specifically \"hepatocellular carcinoma\". This disease often develops in the context of a chronically diseased liver, caused by viral infections, excessive alcohol consumption, or fatty liver. Primarily due to the rise of the latter risk factor, liver cancer is one of the few cancer types whose incidence continues to increase globally, year after year. As a result, liver cancer has become the third most common cause of cancer-related deaths worldwide. There exists a significant challenge in reducing the disease on all fronts: prevention, diagnosis, and treatment.\n\nThis research aims to personalize the treatment of liver cancer patients, tailoring it to the individual. More specifically, this research seeks to identify patients with immunotherapy-sensitive liver cancer by biomarkers before treatment begins. Determining whether a tumor is immunotherapy-sensitive is internationally recognized as one of the most important challenges within this condition. Based on a combination of existing laboratory techniques on tumor tissue and\u002For blood, the investigators seek to predict the likelihood of this treatment's success before initiating it. With this knowledge, the investigators could recommend alternative treatments to patients with tumors that are unresponsive. This way, they would also avoid exposure to the side effects of an ineffective therapy.",[26],[663,532,463],"Biomarker",{"date":539,"type":37},{"date":666,"type":37},"2025-03-04",{"date":668,"type":22},"2032-01",{"name":670,"class":44},"Universitaire Ziekenhuizen KU Leuven",4]