[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-hepatocellular\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-hepatocellular":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,50,83,115,142,160,193,215,238,259,290,311,336,357,383,416,436,457,478,498,517,543,568,593,617],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100476640","preventing-liver-cancer-mortality-through-imaging-with-ultrasound-vs-mri-100476640",false,"NCT05486572","Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI","CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)","PREMIUM","Inclusion Criteria:\n\n1. Cirrhosis due to any underlying etiology diagnosed by one or more of the following:\n\n   * Histology of liver biopsy\n   * Radiologic criteria (nodular liver, evidence of portal hypertension)\n   * Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy)\n   * Vibration controlled transient elastography (VCTE, specifically Fibroscan, which is available in all participating sites) with liver stiffness \\>12.5kPa or magnetic resonance elastography \\>5.0 kPa\n2. High Risk of Liver Cancer: This will be defined by one or more of the following:\n\n   * Current HCV infection (detectable HCV RNA)\n   * FIB-4 score 3.25, within 6 months of randomization\n   * Estimated annual HCC incidence \\>2.5%, within 6 months of randomization, calculated by VA-specific models that the investigators developed (available on the national VA ALD Dashboard and at www.hccrisk.com).\n3. Age 18-75\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Prior diagnosis or of HCC\n2. Current suspicion of HCC\n3. Prior receipt of organ transplantation\n4. Currently listed for organ transplantation.\n5. Participation in a conflicting HCC screening trial\n6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \\>20, within 6 months prior to randomization\n7. Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\n8. Multiple comorbid conditions resulting in limited life expectancy, defined by a cirrhosis-specific comorbidity index (CirCom)112 score 3. Of note, early stage malignancies of the bladder, lung, or prostate will not be excluded.\n9. Estimated life expectancy \\\u003C5 years as determined by the clinical judgement of the Study Investigator\n10. Contraindications to undergoing contrast-enhanced MRI:\n\n    * Allergy to gadolinium-based contrast agents\n    * MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices)\n    * Implantable neurostimulation device\n    * Implantable cochlear implant\u002Fear implant\n    * Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps)\n    * Metallic foreign bodies in or around the eye\n    * Metallic fragments, such as bullets, shotgun pellets or shrapnel\n    * Metallic body piercings that cannot be removed\n    * Cerebral artery aneurysm clips\n    * Severe claustrophobia\n    * Unable to fit on MRI machine due to weight (weight \\>400lbs) or body habitus\n11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)\n12. Currently pregnant","ALL","18 Years","75 Years",{"count":21,"type":22},4700,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.",[28,29],"Carcinoma, Hepatocellular","Cirrhosis",[31,32,33,34,35,36],"hepatic, oncology","liver","chronic diseases; health services and systems","prospective, randomized, clinical trial","magnetic resonance imaging; ultrasonography","cirrhosis; liver cancer","RECRUITING","2026-06-15",{"date":40,"type":41},"2026-06-17","ACTUAL",{"date":43,"type":41},"2023-11-03",{"date":45,"type":22},"2031-09-01",{"name":47,"class":48},"VA Office of Research and Development","FED",34,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100610394","phase-1-symbiotic-gi-13-a-study-to-learn-about-study-medicine-called-pf-08634404-as-a-single-treatment-and-combination-treatment-in-adult-participants-with-a-liver-cancer-called-hepatocellular-carcinoma-that-is-too-advanced-to-be-removed-by-surgery-and-may-have-spread-to-other-parts-of-the-body-100610394","NCT07227012","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",{"count":58,"type":22},138,[60,61],"PHASE1","PHASE2","The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced or metastatic HCC.\n* Is not a candidate for complete surgical or loco-regional therapies.\n* Have not received any whole-body treatment for HCC.\n\nParticipants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",[28,64,65,66,67,68,69],"Hepatocellular Cancer","Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Liver Neoplasms","Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[65,71,67],"Liver cancer","2026-06-03",{"date":74,"type":41},"2026-06-04",{"date":76,"type":41},"2025-12-01",{"date":78,"type":22},"2028-10-17",{"name":80,"class":81},"Pfizer","INDUSTRY",35,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100577113","efficacy-and-safety-of-multimodal-ablation-combined-with-pd-1-monoclonal-antibody-lenvatinib-and-tace-in-the-treatment-of-unresectable-primary-hepatocellular-carcinoma-a-single-arm-single-center-clinical-study-100577113","NCT06794073","Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender.\n2. Clinically or pathologically confirmed HCC.\n3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.\n4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \\>5 cm.\n5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..\n6. ECOG PS 0-1 and an expected survival \\>3 months.\n7. Child-Pugh score ≤7.\n\nExclusion Criteria:\n\n1. Child-Pugh class C liver dysfunction.\n2. Tumor thrombus in the main portal vein or hepatic vein.\n3. Extensive metastatic disease with an expected survival \\\u003C3 months.\n4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).\n5. History of esophageal\u002Fgastric variceal bleeding within the past month.\n6. History of other malignancies.\n7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \\\u003C1 month.\n8. Active infection; HBV co-infection (HBV DNA ≥2000 IU\u002FmL or ≥10⁴ copies\u002FmL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.\n9. History of organ transplantation or hepatic encephalopathy.\n10. Uncorrectable coagulation disorders.\n11. Refractory massive ascites, pleural effusion, or cachexia.\n12. Pregnancy, impaired consciousness, or inability to comply with treatment.\n13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \\>12).\n14. Any other condition deemed unsuitable by investigators that may affect study participation.","80 Years",{"count":91,"type":22},17,[25],"This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.",[28,95,96,97,67],"Neoplasms, Glandular and Epithelial","Adenocarcinoma","Digestive System Neoplasms",[99,100,101,102,103],"Multimodal","Tislelizumab","lenvatinib","TACE","unresectable primary liver cancer","2026-05-08",{"date":106,"type":41},"2026-05-11",{"date":108,"type":41},"2026-01-31",{"date":110,"type":22},"2027-08-31",{"name":112,"class":113},"Shanghai Zhongshan Hospital","OTHER",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":89,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":114},"100632497","phase-2-regorafenib-after-treatment-failure-of-first-line-immune-checkpoint-inhibitor-treatment-in-advanced-hepatocellular-carcinoma-patients-100632497","NCT07514455","Regorafenib After Treatment Failure of First Line Immune Checkpoint Inhibitor Treatment in Advanced Hepatocellular Carcinoma Patients","Regorafenib After Failure of First-Line Immune Checkpoint Inhibitor-Based Combination Therapy in Child-Pugh B Patients With HCC: A Phase 2 RECOMEND Trial","RECOMEND","Inclusion Criteria:\n\n1. Voluntarily signed written informed consent form.\n2. Age ≥19 years at the time of signing the informed consent form.\n3. Histologically or clinically diagnosed hepatocellular carcinoma (HCC) according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines.\n4. Disease progression or treatment discontinuation due to toxicity during first-line immune checkpoint inhibitor-based combination therapy (atezolizumab plus bevacizumab, durvalumab plus tremelimumab, or nivolumab plus ipilimumab).\n5. At least one measurable target lesion according to RECIST v1.1.\n6. Child-Pugh score B (7-8).Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. Adequate hematologic and end-organ function defined by the following laboratory results obtained within 14 days prior to the test (or enrollment):\n\n   * Hemoglobin ≥ 8.5 g\u002FdL\n   * Absolute Neutrophil Count (ANC) ≥1,200\u002Fmm³\n   * Platelet count ≥60,000\u002FµL\n   * Total bilirubin \\\u003C 3.5 mg\u002FdL\n   * Serum albumin ≥2.5 g\u002FdL\n   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤7 times upper limit of normal (ULN)\n   * Prothrombin time (INR ≤1.8 times ULN)\n   * Serum creatinine ≤2.0 times ULN or calculated creatinine clearance ≥40 mL\u002Fmin (using the Cockcroft-Gault equation)\n\n10\\) Virologic status of hepatitis confirmed and documented by HBV and HCV screening tests.Patients with HBV or HCV infection must receive antiviral therapy according to institutional guidelines.\n\n11\\) Women of childbearing potential must agree to remain abstinent or use effective contraception (with an annual failure rate of \\\u003C 1%) from the time of signing informed consent until at least 6 months after the last dose of the study drug.Male participants must agree to remain abstinent or use effective contraception (with an annual failure rate of \\\u003C 1%) and refrain from sperm donation from the time of signing informed consent until at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. ALBI (Albumin-Bilirubin) grade 3.\n2. Fibrolamellar carcinoma or sarcomatoid carcinoma.\n3. Prior treatment with regorafenib.\n4. Within 2 weeks since the last administration of an immune checkpoint inhibitor.\n5. Receipt of any other systemic or locoregional therapy after the failure of first-line immune checkpoint inhibitor-based therapy.\n6. History of allogeneic stem cell transplantation or solid organ transplantation.\n7. Active brain metastases or leptomeningeal metastases.\n8. History of malignancy other than hepatocellular carcinoma (HCC) within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year survival rate \\> 90%).\n9. Severe cardiovascular disease within 3 months prior to the start of study therapy (e.g., New York Heart Association \\[NYHA\\] Class II or higher heart disease, myocardial infarction, or cerebrovascular accident); unstable arrhythmia or unstable angina; history of gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to the start of study therapy; active gastrointestinal disease with a high risk of bleeding or perforation (e.g., peptic ulcer, inflammatory bowel disease, diverticulitis, cholecystitis, acute pancreatitis); untreated high-risk varices or recent history of variceal bleeding (enrollment is permitted only if at least 28 days have passed since stabilization with standard treatment); prolonged QTc interval (\\> 450 ms for males, \\> 470 ms for females); systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg despite optimal medical therapy; or other significant medical conditions or abnormal findings that, in the opinion of the investigator, may increase the risk associated with study participation.\n10. Female participants who are pregnant or breastfeeding, or male or female participants of reproductive potential who are unwilling to use effective contraception from screening until 6 months after the last dose of the study drug.\n11. Participants deemed by the investigator to be unlikely to comply with study procedures, restrictions, and requirements.\n12. Patients who have received locoregional therapy (e.g., radiofrequency ablation \\[RFA\\], microwave ablation \\[MWA\\], transarterial chemoembolization \\[TACE\\], transarterial radioembolization \\[TARE\\], transarterial embolization \\[TAE\\], radiation therapy, etc.) after the discontinuation of immune checkpoint inhibitor-based combination therapy.","19 Years",{"count":125,"type":22},20,[61],"Immune checkpoint inhibitor (ICI)-based regimens (atezolizumab+bevacizumab, durvalumab+tremelimumab, nivolumab+ipilimumab) are now a first-line standard for advanced hepatocellular carcinoma (HCC). For Child-Pugh (CP) A patients, regorafenib, cabozantinib, and ramucirumab are approved second-line agents, but there is no approved second-line systemic therapy for CP-B. In CP-B historical controls treated with best supportive care, median progression free survival (PFS) was \\~1.4 months in a REACH trial subgroup analysis and \\~1.9 months in a CELESTIAL trial subgroup analysis. Regorafenib demonstrated benefit as a post-sorafenib second-line therapy in CP-A patients in the RESORCE trial, but prospective evidence in CP-B is lacking. A multicenter retrospective study of CP-B patients receiving second-line regorafenib after sorafenib reported a median PFS of 1.8 months, and prospective data after ICI-based first-line therapy are not available.\n\nThis study will evaluate the efficacy and safety of regorafenib as second-line therapy in CP-B patients with disease progression after first-line ICI-based treatment. The primary objective is to demonstrate superiority over historical controls, with PFS as the primary endpoint.\n\nAfter written informed consent, all participants will receive regorafenib. Regorafenib will be administered at 120 mg orally once daily at the same time each day, after a meal with water, for 3 consecutive weeks followed by 1 week off (4-week cycle). Treatment must start within 3 days after screening and will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. After treatment discontinuation, patients will be followed every 12 week (+\u002F-7 days) for survival status and subsequent anticancer therapies, and survival follow-up will continue for at least 12 months after enrollment of the last participant.",[28,129,130,131],"Hepatic Insufficien","Disease Progression","Treatment Failure","NOT_YET_RECRUITING","2026-03-30",{"date":135,"type":41},"2026-04-07",{"date":137,"type":22},"2026-03-15",{"date":139,"type":22},"2028-06-30",{"name":141,"class":113},"Ju Hyun Shim",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":159,"locationsCount":114},"100632495","phase-2-regorafenib-after-failure-of-lenvatinib-in-patients-with-unresectable-hcc-the-relevant-hcc-trial-100632495","NCT07514429","Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial","Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: A Phase 2 RELEVANT-HCC Trial","RELEVANT-HCC","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age ≥ 19 years at the time of signing the informed consent form.\n3. Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines.\n4. Patients with unresectable HCC who have experienced disease progression or treatment discontinuation due to toxicity during prior treatment with lenvatinib.\n5. Presence of at least one measurable target lesion according to RECIST v1.1.\n6. Child-Pugh classification A or B7 (score 7).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n8. Adequate hematologic and end-organ function defined by the following laboratory test results obtained within 14 days prior to testing (or enrollment):\n\n   * Hemoglobin ≥ 8.5 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,200\u002Fmm³\n   * Platelet count ≥ 60,000\u002FμL\n   * Total bilirubin \\\u003C 3.5 mg\u002FdL\n   * Serum albumin ≥ 2.5 g\u002FdL\n   * AST and ALT ≤ 7 × upper limit of normal (ULN)\n   * Prothrombin time (INR ≤ 1.8 × ULN)\n   * Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation)\n9. Virological status of hepatitis confirmed and recorded through HBV and HCV screening.\n\n   * Participants with HBV or HCV infection must be receiving antiviral therapy according to institutional guidelines.\n10. Women of childbearing potential must agree to maintain abstinence or use effective contraception (with an annual failure rate of \\\u003C 1%) from the time of signing the informed consent until at least 6 months after the last dose of the study drug. Male participants must agree to maintain abstinence or use effective contraception (with an annual failure rate of \\\u003C 1%) and refrain from sperm donation from the time of signing the informed consent until at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Albumin-bilirubin (ALBI) grade 3.\n2. Fibrolamellar carcinoma or sarcomatoid carcinoma.\n3. Prior treatment with regorafenib.\n4. History of allogeneic stem cell transplantation or solid organ transplantation.\n5. Active brain metastases or leptomeningeal metastases.\n6. History of malignancy other than hepatocellular carcinoma (HCC) within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year survival rate \\> 90%).\n7. Severe cardiovascular disease within 3 months prior to the start of study therapy (e.g., New York Heart Association \\[NYHA\\] Class II or higher heart disease, myocardial infarction, or cerebrovascular accident); uncontrolled serious medical comorbidities, including unstable arrhythmia or unstable angina; or other significant medical conditions or abnormal findings that, in the opinion of the investigator, may increase the risk associated with study participation.\n8. Female participants who are pregnant or breastfeeding, or male or female participants of reproductive potential who are unwilling to use effective contraception from screening until 6 months after the last dose of the study drug.\n9. Participants deemed by the investigator to be unlikely to comply with study procedures, restrictions, and requirements.\n10. Patients who have received locoregional therapy (e.g., radiofrequency ablation \\[RFA\\], microwave ablation \\[MWA\\], transarterial chemoembolization \\[TACE\\], transarterial radioembolization \\[TARE\\], transarterial embolization \\[TAE\\], radiation therapy, etc.) after discontinuation of lenvatinib treatment.",{"count":151,"type":22},24,[61],"The purpose of this clinical trial is to evaluate the efficacy and safety of regorafenib as a subsequent therapy for patients with hepatocellular carcinoma (HCC) who have failed prior lenvatinib treatment. This investigational study aims to assess the therapeutic benefits and safety profile of regorafenib in patients whose disease has progressed following the use of lenvatinib, a targeted therapy for hepatocellular carcinoma",[28,155,131],"Lenvatinib",{"date":135,"type":41},{"date":137,"type":22},{"date":139,"type":22},{"name":141,"class":113},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100568953","phase-1-a-study-to-evaluate-the-tolerability-safety-and-pk-of-ast-201-in-patients-with-gpc3-positive-advanced-solid-tumors-100568953","NCT06687941","A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors","A Multi-center, Open-label, Dose Escalation and Expansion, Phase 1 Study to Evaluate the Tolerability, Safety and Pharmacokinetics of AST-201 in Patients With GPC3-positive Advanced Solid Tumors","Inclusion Criteria\n\n* Male and female aged ≥19 years\n* Histologically and\u002For cytologically diagnosed as the advanced recurrent solid tumor\n* GPC3-positive confirmed by IHC test\n* At least 1 measurable or non-measurable but evaluable lesion as defined per RECIST v1.1 (modified RECIST for hepatocellular carcinoma)\n* ECOG performance status of 0 or 1\n* Life expectancy at least 12 weeks\n* Adequate hematologic, hepatic, renal, and heart\u002Fcoagulation function\n* Child-Pugh Class of A for HCC\n\nExclusion Criteria\n\n* Subjects with ischemic heart disease\n* Subjects with anti-tumor treatment within 4 weeks\n* Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc.\n* Pregnant or potentially pregnant and lactating woman",{"count":168,"type":22},70,[60],"This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.",[172,28,173,67],"Neoplasms","Carcinoma, Non-Small-Cell Lung",[175,176,177,178,179,180,181,182],"Glypican-3 (GPC3)","GPC3-positive advanced solid tumors","AST-201","Aptamer-drug conjugate","Hepatocellular carcinoma (HCC)","Advanced solid tumors","Metastatic","Dose Escalation and Expansion","2026-03-23",{"date":185,"type":41},"2026-03-27",{"date":187,"type":41},"2025-03-11",{"date":189,"type":22},"2028-05",{"name":191,"class":81},"Aptamer Sciences, Inc.",4,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":114},"100593750","phase-2-a-prospective-study-to-evaluate-the-safety-and-efficacy-of-the-combination-therapy-of-irpagratinib-atezolizumab-and-bevacizumab-in-patients-with-hepatocellular-carcinoma-100593750","NCT07010497","A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma","A PHASE 2, OPEN-LABEL STUDY OF IRPAGRATINIB IN COMBINATION WITH ATEZOLIZUMAB AND BEVACIZUMAB IN PATIENTS WITH ADVANCED OR UNRESECTABLE HEPATOCELLULAR CARCINOMA (IAPETUS)","IAPETUS","Inclusion Criteria:\n\n* 1.Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n* 2.Male or female, aged ≥19 at the time of signing inform consent form.\n* 3.Patients must have histological or cytological confirmed advanced or unresectable HCC not amenable to curative surgical or loco-regional therapies. And patients must satisfy:\n\n  1. Provide archived tissue sample for FGF19 overexpression detection.For Safety-Run in and Expansion: the result of FGF19 overexpression lab testing must be positive as defined. Only tissue from primary lesion of liver is eligible.\n  2. Barcelona Clinic Liver Cancer (BCLC) stage B or C and Child-Pugh score 5\\~6 without hepatic encephalopathy, no clinically apparent ascites or require medical intervention.\n  3. Have at least 1 target lesion (per RECIST v1.1). Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, transarterial (chemo) embolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed per RECIST v1.1.\n* 4.ECOG performance status score 0-1\n* 5.Life expectancy ≥ 3 months\n* 6.Adequate organ and hematologic function as indicated by the following screening assessments performed within 14 days prior to the first administration (without blood transfusion, or medication with stimulation factors or thrombopoietin receptor agonists (TPO-RAs) within 14 days before blood sample collection):a) Absolute neutrophil count (ANC) ≥1.0×109\u002FLb) Platelet count (PLT) ≥75×109\u002FLc) Hemoglobin (Hb) ≥85g\u002FL (8.5g\u002FdL)d) Total bilirubin (TBIL) ≤3×ULNe) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ×ULNf) Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL\u002Fmin based on Cockcroft-Gault formulag) For patients not receiving therapeutic anticoagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤2×ULN.h) Urinalysis for proteinuria \\\u003C2+ (patients discovered to have ≥2+ proteinuria on urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \\\u003C1g of protein in 24 hours)\n* 7.Non-surgically sterilized male or female patients of childbearing potential must agree to use effective methods of birth control during the study and for up to 6 months after the last dose of study drug. Non-surgically sterilized female patients of childbearing potential must in non-lactation period and have a negative β-HCG test result within 14 days before first administration.\n\nExclusion Criteria:\n\nPrior\u002FConcomitant Therapy\n\n* 1\\. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced\u002Funresectable HCC. Patient who has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.\n* 2\\. Has received prior therapy with immune checkpoint inhibitors or immune stimulatory agents (eg, anti-PD-1, anti-PD-L1\u002F2, anti-CTLA-4, anti-TIGIT, OX-40, or CD137). Patients has received one cycle of Atezolizumab plus Bevacizumab is eligible for this trial.\n* 3\\. Previous treatment with FGFR inhibitors including selective FGFR4 or pan-FGFR inhibitors.\n* 4\\. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study intervention.\n* 5\\. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure \\>30%), loco-regional treatment \\\u003C4 weeks; endocrine therapy with anti-tumor indications for \\\u003C 2 weeks.\n* 6\\. Prior toxicities from radiotherapy and other anti-cancer therapies that have not recovered to Grade ≤1 (CTCAE v5.0) except for which eligibility criteria allowed, alopecia, vitiligo, hormone replacement therapy controlled stable hypothyroidism, and Grade ≤2 neurotoxicity or toxicities related to prior one cycle of Atezolizumab plus Bevacizumab that investigator believes don't affect patients and safety assessment.\n* 7\\. Concomitant use of P-gp transporter inhibitors; as well as moderate or strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, Seville oranges or juice or products) within at least 14 days prior to the first dose of the study drug.\n* 8\\. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to initiation of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial (except for patients who received one-time, acute, low-dose prednisone \\\u003C7.5 mg\u002Fd or equivalent corticosteroids).\n* 9\\. Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).\n* 10\\. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDS for the symptomatic relief of medical conditions such as headache or fever is allowed.\n* 11\\. Active infection or unexplained fever \\> 38.5℃ or last treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to the first dose of study treatment.\n\nFactors related to the disease\n\n* 12\\. Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.\n* 13\\. Has a known active central nervous system (CNS) metastasis.\n* 14\\. Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (\\\u003C30 mm from the carina) of large volume. Patients with vascular invasion of the portal or hepatic veins may be enrolled.\n* 15\\. Patients with refractory\u002Funcontrolled ascites, pleural effusion or pericardial effusion requiring intervention within 2 weeks before administration of study treatment.\n* 16\\. History of hepatic encephalopathy.\n* 17\\. Liver tumor as a percentage of liver ≥ 50% as judged by the investigator.\n* 18\\. Vp4 type portal vein tumor thrombus and beyond (such as inferior vena cava).\n* 19\\. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk for bleeding or a prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment.\n* 20\\. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of Bevacizumab.\n* 21\\. History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.\n\nDiagnostic Assessments\n\n* 22\\. History of second primary malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, etc.\n* 23\\. Known allergy or hypersensitivity to any component of the investigational drug product formulation or history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. Known hypersensitivity to Chinese hamster ovary cell products.\n* 24\\. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, etc. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) that don't require systemic treatment are eligible for the study. For uncertain autoimmune disease, it could be discussed with the sponsor.\n* 25\\. Prolongation of QTcF (\\> 470 ms \\[average of three ECGs\\], QTc interval corrected by Frederica's formula, QTcF=QT\u002FRR0.33) at screening, and other ECG abnormalities with clinical significance by the judge of the investigator and affect the patient's safety assessment.\n* 26\\. Left ventricle ejection fraction\\\u003C50%.\n* 27\\. Impaired cardiac function or clinically significant cardiac disease, including but not limit to any one of the following: New York Heart Association class III or IV congestive heart failure, unstable angina, or myocardial infarction within 6 months before administration of the study drug. Any cardiac arrhythmia requiring treatment or intervention. Uncontrolled hypertension (Systolic blood pressure≥150mmHg and\u002For diastolic blood pressure≥100mmHg).\n* 28\\. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment.\n* 29\\. Any serious acute or chronic infection requiring systemic anti-infective therapy (except for viral hepatitis, see exclusion criteria 31-33).\n* 30\\. History of immunodeficiency, including HIV antibody serum test positive, or other acquired\u002Fcongenital immunodeficiency disease, or active tuberculosis.\n* 31\\. Patients with HBV infection should follow local clinical practice and anti-HBV therapy should be performed to ensure adequate viral suppression. HBV-DNA ≥2000 IU\u002FmL (or equivalent copies\u002FmL) obtained within 14 days prior to initiation of study treatment.\n* 32\\. Patients with HBV and HCV co-infection. If there is only a history of HCV infection, but HCV RNA (-), it is not regarded as HCV infection.\n* 33\\. Patients with active HCV infection (HCV-RNA\\>103 copies\u002FmL or following local clinical practice) or require concomitant anti-HCV therapy during the study.\n* 34\\. Any other clinically significant comorbidities, such as respiratory, metabolic, congenital, endocrine or central nervous system disease, or any other medical conditions, mental disturbances or social determinants, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.\n\nOther Exclusions\n\n* 35\\. History of allogeneic stem cell transplantation or organ transplantation.\n* 36\\. History of hemoptysis (≥2.5mL of bright red blood per episode) within 1 month prior to initiation of study treatment.\n* 37\\. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n* 38\\. Current or recent (within 10 days prior to study treatment start) use of aspirin (\\>325 mg\u002Fday) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n* 39\\. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anti-coagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.\n* 40\\. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR\\\u003C1.5×ULN and APTT is within normal limits within 14 days prior to initiation of study treatment.\n* 41\\. For prophylactic use of anti-coagulants or thrombolytic therapies, local label approved dose levels may be used.\n* 42\\. Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.\n* 43\\. Inability to take oral medication or other factors significant preclude adequate absorption of oral medication, such as previously received total gastrectomy, residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome after small bowel resection, active diarrhea or severe irritable bowel syndrome required drug treatment, etc.",{"count":202,"type":22},33,[61],"This is a phase 2, open-label study to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Atezolizumab and Bevacizumab in patients with advanced or unresectable HCC harboring FGF19 overexpression.\n\nThis study composes two parts, a Safety Run-in part to evaluate safety and establish the dose of Irpagratinib for the triple combination, and an Expansion part to evaluate the preliminary efficacy and safety using Simon's two-stage design.",[28],"2026-03-17",{"date":208,"type":41},"2026-03-18",{"date":210,"type":41},"2026-03-16",{"date":212,"type":22},"2029-03-31",{"name":214,"class":113},"Asan Medical Center",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100467443","phase-2-tislelizumab-consolidation-after-liver-directed-therapy-for-hepatocellular-carcinoma-100467443","NCT05366829","Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Each patient eligible to participate in this study must meet all the following criteria:\n\n  1. Written informed consent\n  2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted\n  3. Hepatocellular carcinoma diagnosis by histologic findings and\u002For imaging criteria of LI-RADS 5\n  4. Eastern Cooperative Oncology Group performance status score of 0-2\n  5. Age\\>\u002F=18 years\n  6. Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation\n  7. No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen\u002Fliver and chest CT.\n  8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug\n  9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for \\> 6 months after treatment stop.\n  10. Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1.\n  11. Demonstrate adequate bone marrow and organ function as defined below:\n\n      1. Hematologic - Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL, Hemoglobin \\> 8.5 g\u002FdL, Platelet count ≥ 75,000\u002FmcL\n      2. Renal - Serum creatinine OR calculated\\* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL\u002Fmin for participants with creatinine levels \\> 1.5x institutional ULN\n\n         * Calculate serum creatinine clearance using the standard Cockcroft-Gault formula.\n\n         Urine protein Urine dipstick for proteinuria \\\u003C 2+ within 7 days prior to start of study treatment \\*Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate \\\u003C 1g of protein in 24 hours\n      3. Hepatic - Serum total bilirubin ≤ 3 mg\u002FdL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN \\*This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.\n\n         Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields\n  2. Prior selective internal radiotherapy\u002Fhepatic arterial Yttrium therapy, at any time\n  3. Severe, active co-morbidity as per investigator\n  4. More than five discrete intrahepatic parenchymal foci of definite HCC or left\u002Fright or main portal vein thrombus\n  5. Direct tumor extension into the stomach, duodenum, small bowel or large bowel\n  6. Measurable common or main branch biliary duct involvement with HCC\n  7. Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) \\> 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions).\n\n     Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \\> 2.0 cm.\n  8. Prior liver transplant\n  9. HIV positive\n  10. Immunodeficiency requiring chronic systemic therapy or that may relapse\n  11. Participants who have received prior immunotherapy.\n  12. Participants with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control\n\n      a. Note: Participants with ascites who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for two months days prior to the first dose of study treatment are eligible.\n  13. Participants with clinically meaningful encephalopathy\n  14. Participants who have undergone prior solid organ or bone marrow transplant except for patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection.\n  15. Patients must have documented hepatitis virology status.\n\n      a. Participants with active hepatitis B virus (HBV) infection must have a viral load \\\u003C 500 IU\u002FmL within 28 days prior to start of Tislelizumab and be on suppressive therapy (per local standard of care) for a minimum of fourteen days prior to start of study treatment and for the length of the study. b. Participants with co-infection with HBV and hepatitis C virus (HCV) are excluded.\n\n      c. Participants with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV and can enroll.\n  16. Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible.\n  17. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.\n  18. Participants with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers \\\u003C 10% of body surface area (BSA), disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).\n  19. Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g. resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n  20. Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment with Tislelizumab.\n\n      1. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n  21. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug a. Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: i. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) ii. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption iii. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non- autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)\n  22. With uncontrolled diabetes or \\> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug\n  23. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.\n  24. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.\n  25. Severe infections within 4 weeks before first dose of study drug, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n  26. Received therapeutic oral or intravenous antibiotics within two weeks before first dose of study drug\n  27. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug\n  28. Any of the following cardiovascular risk factors:\n\n      a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug\n  29. Has received any herbal medicine used to control cancer within fourteen days of the first study drug administration\n  30. Participants with toxicities (because of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)\n  31. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study c conduct.\n  32. Concurrent participation in another therapeutic clinical study.",{"count":82,"type":22},[61],"The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.",[28,225],"Liver Cell Carcinoma",[227,100,65],"Liver-Directed Therapy","2026-01-15",{"date":230,"type":41},"2026-01-20",{"date":232,"type":41},"2022-07-25",{"date":234,"type":22},"2027-06-01",{"name":236,"class":113},"Rutgers, The State University of New Jersey",2,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":114},"100354438","characterizing-disease-biology-treatment-and-toxicity-in-older-adults-with-hepatocellular-carcinoma-100354438","NCT03894917","Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma","Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Histologically or radiographically (CT or MRI) confirmed newly diagnosed hepatocellular carcinoma.\n* Age 18 years and older.\n* Patients with advanced, unresectable HCC as determined by the treating physician.\n\nExclusion Criteria:\n\n* Patients with resectable HCC who are still candidates for locoregional therapy\n* Patients receiving prior systemic or locoregional therapy",{"count":246,"type":22},84,"OBSERVATIONAL","This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants.",[28],"2026-01-05",{"date":252,"type":41},"2026-01-08",{"date":254,"type":41},"2019-09-13",{"date":256,"type":22},"2027-12",{"name":258,"class":113},"The University of Texas Health Science Center at San Antonio",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100522562","phase-4-national-liver-cancer-screening-trial-100522562","NCT06084234","National Liver Cancer Screening Trial","TRACER","Inclusion Criteria:\n\nPatient must meet all of the following inclusion criteria:\n\n1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment\n2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator\n3. Able to provide informed consent\n4. Life expectancy \\>6 months (after consent) as determined by the treating provider or site investigator\n\nExclusion Criteria:\n\nPatient will be excluded for any of the following exclusion criteria:\n\n1. Child Pugh C cirrhosis\n2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma\n3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT\u002FMRI demonstrating benign nature)\n4. AFP \\>20 ng\u002FmL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions\n5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent\n6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent\n7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent\n8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward\n9. History of a transjugular intrahepatic portosystemic shunt (TIPS)\n10. History of Fontan associated liver disease or cardiac cirrhosis\n11. History of solid organ transplantation\n12. Actively listed for liver transplantation\n13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent\n14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)\n15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent\n16. Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)\n17. In patients living with HIV: CD4+ T cell count less than 100 cells\u002Fmm3 within 60 days prior to consent\n18. Known pregnancy at consent\n19. Active warfarin use","85 Years",{"count":268,"type":22},5500,[270],"PHASE4","The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.",[28,273,274,275],"Liver Cancer","Liver Cirrhosis","Hepatitis B",[277,278,279],"Hepatocellular carcinoma surveillance","GALAD","Alpha Fetoprotein","2025-11-25",{"date":282,"type":41},"2025-11-26",{"date":284,"type":41},"2023-12-26",{"date":286,"type":22},"2034-12-31",{"name":288,"class":113},"University of Texas Southwestern Medical Center",18,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100605272","phase-4-exploration-of-postoperative-adjuvant-therapy-for-hcc-patients-with-positive-tb-100605272","NCT07160361","Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB","Exploration of Postoperative Adjuvant Therapy for Hepatocellular Carcinoma Patients With Positive Tumor Budding","Inclusion Criteria:\n\n* Age is ≥18 years old, male or female;\n* Histologically confirmed as hepatocellular carcinoma without metastasis;\n* Tumor budding is positive\n* Life expectancy of at least 12 weeks;\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma that cannot be surgically resected\n* Received radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. before surgery\n* Pregnant or lactating women\n* Subjects with other malignant tumors;\n* Subjects who are considered unsuitable to participate in this cohort study by the investigator;\n* Subjects who refuse to enroll or do not sign the informed consent form;\n* Subjects with incomplete medical record information (including gender, age, diagnostic information, imaging (and) or pathological diagnosis results, other demographic data, etc.).",{"count":298,"type":22},56,[270],"Hepatocellular carcinoma (HCC) is one of the most common types of primary liver cancer worldwide, characterized by complex and variable disease progression and significant treatment challenges. Among HCC patients, tumor budding (TB) is associated with a high risk of postoperative recurrence, significantly impacting patient prognosis. Even in the current HCC pathological diagnosis \"gold standard\" of MVI-negative patients, TB retains excellent prognostic predictive value. TB cells reside within the peritumoral stroma, where dense collagen fibers restrict the efficacy of therapeutic agents including chemotherapy, immunotherapy, and targeted therapies, making it difficult for single-agent treatments to effectively eliminate TB. Therefore, specific treatment strategies should be considered for TB-positive patients to improve survival outcomes and reduce the risk of tumor recurrence. To address this clinical challenge, this study aims to clarify the prognostic impact of combining collagen degradation therapy with targeted therapy in TB-positive HCC patients. Through a single-arm trial (postoperative targeted therapy + collagen degradation therapy), investigators explore the clinical efficacy and prognostic indicators of this combination approach, seeking the optimal treatment strategy for TB-positive HCC patients. Collagen degradation therapy facilitates drug delivery to tumor-bottle lesions by degrading collagen barriers, while targeted therapy specifically intervenes against cancer cells. Their combination holds promise for synergistic effects and enhanced therapeutic outcomes. This study aims to preliminarily assess the impact of this dual approach on prognosis, providing evidence for personalized treatment strategies. The findings of this research hold promise for delivering new breakthroughs in the treatment of TB-positive HCC patients, improving their quality of life and survival rates, and providing robust support for future clinical practice.",[28],"2025-09-10",{"date":304,"type":41},"2025-09-16",{"date":306,"type":22},"2025-10-01",{"date":308,"type":22},"2029-12-31",{"name":310,"class":113},"Second Affiliated Hospital of Xi'an Jiaotong University",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":114},"100512554","90y-transarterial-radioembolization-versus-microwave-ablation-in-small-hepatocellular-carcinoma-with-hypoalbuminemia-100512554","NCT05953961","90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia","Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia","REALM","Inclusion Criteria:\n\n* HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines\n* Eastern Cooperative Oncology Group score 0 - 1\n* Child-Pugh A - B\n* Bilirubin \\\u003C 2.5 mg\u002FdL\n* Creatinine \\\u003C 2.0 mg\u002FdL\n* No prior liver-directed therapy or systemic therapy for HCC\n* Solitary, unresectable HCC ≤ 3cm\n* Albumin level \\\u003C 3.4 g\u002FdL at HCC diagnosis\n* Tumor anatomical location and angiosome amendable to MWA and 90Y\n\nExclusion Criteria:\n\n* Pregnant women\n* Concurrent malignancy",{"count":320,"type":22},50,[25],"This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.",[28],[325,326],"Yttrium-90","Hypoalbuminemia","2025-07-30",{"date":329,"type":41},"2025-08-03",{"date":331,"type":41},"2023-08-08",{"date":333,"type":22},"2027-01",{"name":335,"class":113},"Ochsner Health System",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":114},"100573177","phase-2-a-phase-ii-clinical-study-to-evaluate-hlx43-in-patients-with-locally-advanced-or-metastatic-hcc-failed-or-intolerance-to-standard-therapy-100573177","NCT06742892","A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy","A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures\n2. The age of signing ICF is ≥ 18 years old and ≤ 75 years old，regardless of gender;\n3. Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or clinically meeting the American Association of Hepatology (AASLD) criteria for HCC diagnosis；\n4. Previous failure or progression of at least one standard systemic therapy for hepatocellular carcinoma (standard therapy refers to PD-1\u002F L1-based combination therapy, or lenvatinib, sorafenib), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.\n5. Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.\n6. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards；\n7. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；\n8. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；\n9. Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A；\n10. The ECOG physical performance score of 0-1 in the week prior to randomization；\n11. Expected survival ≥ 3 monthes；\n12. Subjects of HBsAg (-) and HBcAb (-) are allowed to be enrolled. If HBsAg (+) or HBcAb (+), then HBV-DNA must be \\\u003C 500 IU\u002FmL or \\\u003C2500 copy\u002Fml or \\\u003CULN to be eligible for enrollment. Subjects with negative HCV antibodies (-) or negative HCV-RNA are allowed to be included in the study. Subjects with negative HCV antibodies (-) or negative HCV-RNA are allowed to be included in the study. If HCV-RNA is positive, consent must be obtained to receive the local standard antiviral treatment, and participants must have ALT and AST levels ≤ 3×ULN to be eligible for enrollment. Subjects with co-infection of hepatitis B and hepatitis C need to be excluded (both HBV-DNA and HCV-RNA are positive)；\n13. Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)；\n14. Male and female subjects of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known;\n2. History of any second malignant tumor within the first 2 years prior to randomization, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma;\n3. History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation;\n4. Within 6 months prior to randomization, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal\u002Fgastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding;\n5. According to the images, portal vein invasion, inferior vena cava or cardiac involvement of HCC main portal branch (Vp4) were present. Patients with cancer thrombus in main portal vein but smooth blood flow in contralateral branch can be enrolled;\n6. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;\n7. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;\n8. Received major surgery or any local treatment targeting liver lesions (including but not limited to surgery, radiotherapy, hepatic artery embolization, transcatheter arterial chemoembolization (TACE), hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to randomization;\n9. Received radiation therapy within the last 4 weeks and abdominal\u002Fpelvic radiation therapy within the previous 8 weeks, excluding palliative radiation therapy for bone disease;\n10. Patients with previous and current cases of interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity;\n11. Known history of severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the trial drug formulation;\n12. Within the 2 weeks prior to randomization, there is the presence of an active systemic infectious disease requiring intravenous antibiotic treatment;\n13. Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg despite active treatment);\n14. A history of ≥ Grade 3 immune-related adverse events during previous immunotherapy;\n15. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;\n16. Received systemic corticosteroids (prednisone \\>10 mg\u002Fday or an equivalent dose of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose; with the following exceptions: use of topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment during situations such as the use of contrast agents;\n17. Live vaccinations or attenuated live vaccinations should not be administered within 4 weeks prior to the initial dosing. Administration of inactivated viral vaccines for seasonal influenza is permitted;\n18. Used strong inhibitors or strong inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization;\n19. Active tuberculosis\n20. Human immunodeficiency virus (HIV) infection;\n21. Pregnant or lactating women;\n22. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.",{"count":344,"type":22},90,[61],"The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy",[28],"2025-03-05",{"date":350,"type":41},"2025-03-10",{"date":352,"type":41},"2025-03-03",{"date":354,"type":22},"2027-06-05",{"name":356,"class":81},"Shanghai Henlius Biotech",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":114},"100485097","stereotactic-body-radiation-therapy-for-the-safety-and-prognosis-of-small-intrahepatic-recurrent-hcc-100485097","NCT05596630","Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC","A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 1\\. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.\n\n  2\\. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement.\n\n  4\\. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml.\n\n  5\\. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency.\n\n  6\\. Hemoglobin (Hb)≥8g\u002FdL ; white blood cell (WBC) ≥ 2\\*10\\^9\u002FL ; neutrophils (ANC) ≥ 1.0\\* 10\\^9\u002FL ; platelet (Pt) ≥ 50\\*10\\^9\u002FL.\n\n  7\\. Men or women with fertility are willing to take contraceptive measures in the trial.\n\n  8\\. ECOG score standard 0 \\~ 1 ; child-pugh score A-B . 9. Expected survival period \\> 3 months. 10. Voluntary participation and signing of informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.\n\n  3\\. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%.\n\n  4\\. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years).\n\n  6\\. Participants in other clinical trials within 30 days prior to study treatment.\n\n  7\\. The distance between the tumor and the gastrointestinal tract \\\u003C 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures.\n\n  9\\. Patients with drug addiction such as drugs, long-term alcoholism, and AIDS. 10. Patients have an uncontrollable epileptic seizure, or lose insight due to mental illness.\n\n  11\\. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.",{"count":365,"type":22},40,[25],"Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%.\n\nStereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies.\n\nWe intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.",[369],"Carcinoma; Hepatocellular",[371,372,373],"Stereotactic Body Radiation Therapy","Recurrent Hepatocellular Carcinoma","Small liver cancer","2025-02-05",{"date":376,"type":41},"2025-02-10",{"date":378,"type":41},"2023-05-01",{"date":380,"type":22},"2027-12-31",{"name":382,"class":113},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":391,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":403,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":114},"100548546","phase-2-a-value-driven-study-on-reducing-immune-checkpoint-inhibitor-dosing-frequency-in-advanced-cancers-100548546","NCT06422403","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)","VALUE-CHECK","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study-specific procedure\n2. Patients with one of the following:\n\n   * Cohort A: Previously untreated locally advanced\u002Fmetastatic HER2 -ve gastric\u002Fgastroesophageal junction\u002Fesophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab.\n   * Cohort B: Previously untreated locally advanced\u002Fmetastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab.\n   * Cohort C: Previously untreated locally advanced\u002Fmetastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR\u002FALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy\n3. Measurable disease per RECIST 1.1 criteria\n4. ECOG Performance status is 0-2\n5. Normal organ and bone marrow function measured within 28 days before the study as defined below:\n\n   * Haemoglobin ≥ 8.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * No features suggestive of MDS\u002FAML on peripheral blood smear\n   * White blood cells (WBC) \\> 3x10\\^9\u002FL\n   * Platelet count ≥ 100 x 10\\^9\u002FL\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n   * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)\n6. A life expectancy ≥ 12 weeks in all patients.\n7. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:\n8. The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n9. Women \\\u003C50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.\n10. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio\n11. Male patients should be willing to use barrier contraception\n12. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.\n13. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements\n\nExclusion Criteria:\n\n1. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.\n2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n3. Unstable spinal cord compression\u002Fbrain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.\n4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.\n5. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n6. Autoimmune disorders\n7. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry\n8. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements\n9. Previous allogeneic bone marrow transplant.","21 Years","99 Years",{"count":394,"type":22},360,[61],"This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced\u002Funresectable gastric\u002Fgastroesophageal junction\u002Foesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.",[28,398,399,400,401,402],"Gastric Adenocarcinoma","GastroEsophageal Cancer","Oesophageal Cancer","Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma",[404,405,406,407],"Nivolumab","Atezolizumab","Pembrolizumab","Extended dosing interval","2025-01-08",{"date":410,"type":41},"2025-01-10",{"date":412,"type":41},"2024-11-25",{"date":308,"type":22},{"name":415,"class":113},"National University Hospital, Singapore",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":114},"100542985","phase-2-a-study-to-explore-the-reasonable-dosage-and-evaluate-the-efficacy-safety-and-tolerability-of-hlx10-and-hlx04-with-or-without-hlx53-in-untreated-locally-advanced-or-metastatic-hepatocellular-carcinoma-patients-100542985","NCT06349980","A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.","A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures\n2. The age of signing ICF is ≥ 18 years old\n3. For patients with cirrhosis, clinical diagnosis is conducted through the American Association for the Study of Liver Diseases (AASLD) standards, while non-cirrhotic patients require a diagnosis confirmed by histological examination.\n4. No prior systemic treatment for HCC.\n5. Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.\n6. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. The measurable target lesion should not have undergone any prior local treatment (such as radiotherapy, radiofrequency ablation, transarterial chemoembolization (TACE), high-intensity focused ultrasound (HIFU), etc.). A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards.\n7. Tumor tissue required for an evaluable PD-L1 expression result at Screening period, if available\n8. Palliative radiotherapy for bone metastatic lesions was initiated at least 2 weeks prior to the first administration and ≥4 weeks have elapsed since the last therapy; diagnostic liver biopsy was performed at least 1 week prior to the first administration of the medication in this study. Previous local treatment-related AEs have resolved to an NCI-CTCAE grade of ≤ 1.\n9. Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A and good grade B (≤ 7 points).\n10. The ECOG physical performance score within 7 days before the first administration of the study drug was 0 or 1.\n11. Expected survival ≥ 12 weeks.\n12. Adequate hematologic and end-organ function.\n\nExclusion Criteria:\n\n1. Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.\n2. History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation.\n3. Within 6 months prior to the first administration of treatment, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal\u002Fgastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding.\n4. According to the images, portal vein invasion, inferior vena cava or cardiac involvement of HCC main portal branch (Vp4) were present. Patients with cancer thrombus in main portal vein but smooth blood flow in contralateral branch can be enrolled.\n5. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases.\n6. History of any second primary malignancy within 2 years prior to the first administration of the drug, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma.\n7. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently).\n8. Human immunodeficiency virus (HIV) infection.\n9. Active tuberculosis.\n10. Patients with previous and current cases of interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity.\n11. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study.\n12. Within 14 days prior to the first administration of the study drug, any active infection requiring systematic anti-infective treatment occurs.\n13. Manifestations of bleeding (including hemoptysis, abnormal vaginal bleeding, etc.) during screening period, or Grade 2 bleeding events within 3 months before signing the informed consent form, and Grade 3 or higher bleeding events within the past 6 months.\n14. Known history of severe allergies to any monoclonal antibodies or excipients used in the study medication.\n15. Previous treatment with any T cell co-stimulation or immune checkpoint therapy (e.g., CTLA-4, PD-1 inhibitors, PD-L1\u002F2 inhibitors, etc.), or previous treatment with bevacizumab or its biosimilars, or previous treatment with anti-TIGIT therapy or related targets (such as CD155, CD112, or CD113 antibodies, etc.).\n16. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.",{"count":424,"type":22},117,[61],"The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.",[28],"2024-12-15",{"date":430,"type":41},"2024-12-18",{"date":432,"type":41},"2024-08-05",{"date":434,"type":22},"2027-02-10",{"name":356,"class":81},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":17,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":114},"100348138","phase-1-a-study-of-ptx-9908-injection-for-non-resectable-hcc-with-tace-100348138","NCT03812874","A Study of PTX-9908 Injection for Non-resectable HCC with TACE","Phase I\u002FII Study of PTX-9908 Injection As an Inhibitor of Cancer Progression in Patients with Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment","Inclusion Criteria:\n\n1. Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A\u002FB with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.\n2. Recovered from TACE treatment and procedure related toxicities including ALT\u002FAST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).\n3. ECOG (Eastern Cooperative Oncology Group) performance status \\\u003C 2.\n4. Have adequate organ and marrow function as defined below:\n\n   1. Absolute neutrophil count \\> 1,200\u002FµL\n   2. Hemoglobin \\> 9 g\u002FdL\n   3. Platelets \\> 100,000\u002FµL\n   4. Total bilirubin \\\u003C 2 X ULN\n5. Have adequate kidney function as estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin\u002F1.73m2\n6. A negative pregnancy test at screening. This applies to any female patient with childbearing potential.\n7. Agree to use adequate contraception after signing informed consent form, during the duration of study participation and for at least 4-weeks after completion or withdrawal from the study. This applies to any female patient with childbearing potential and any male patient whose female partner has childbearing potential.\n\n   Acceptable contraceptive methods include:\n   1. Established use of oral, injected or implanted hormonal methods of contraception\n   2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n   3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) \\>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)\n8. \\>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)\n9. Anticipated life expectancy of \\>= 6 months at assessment during screening.\n10. Ability to understand and have signed a written informed consent document.\n\nExclusion Criteria:\n\n1. 1\\. Patient with Child-Pugh B8-9.\n2. Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.\n3. Patient who has received any other investigational agents within 4 weeks prior to the screening visit.\n4. Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.\n5. Patient with known brain metastases, leptomeningeal or epidural metastases (unless treated and well controlled for \\>= 3 months).\n6. Patient with prior history of co-malignancies, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell\u002Fsquamous cell skin cancer.\n7. Patient with history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease.\n8. Patient with history of positive serology for human immunodeficiency virus (HIV).\n9. Patient with active, uncontrolled bacterial, viral, or fungal infections, which require systemic therapy.\n10. Patient with poor liver function as indicated by serum bilirubin \\> 2 mg\u002FdL, Child-Pugh Class C, severe coagulopathy (INR \\> 2) not correctable with vitamin K, or active hepatic encephalopathy.\n11. Patient with known allergic reactions to biological agent or polypeptides similar to PTX-9908 Injection.\n12. Woman who is pregnant or nursing.\n13. Patient with concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.\n14. Patient with unwillingness or inability to comply with the study protocol for any reason.\n15. A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula\n16. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n17. The use of concomitant medications that prolong the QT\u002FQTc interval","20 Years",{"count":320,"type":22},[60,61],"This is a multicenter, Phase I\u002FII study in patients with non-resectable hepatocellular carcinoma following TACE treatment.\n\nPhase I (Open-label dose escalation)\n\nThis study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg\u002Fkg, and 2 mg\u002Fkg) is planned. For the dose levels in the standard phase (4 mg\u002Fkg, 8 mg\u002Fkg and 16 mg\u002Fkg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period.\n\nPhase II (Randomized placebo controlled dose expansion)\n\nThe objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.",[28],"2024-11-18",{"date":450,"type":41},"2024-11-21",{"date":452,"type":41},"2020-10-06",{"date":454,"type":22},"2026-12-30",{"name":456,"class":81},"TCM Biotech International Corp.",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":114},"100559996","perioperative-risk-of-immunotherapy-based-neoadjuvant-and-conversion-therapy-for-hepatocellular-carcinoma-100559996","NCT06571396","Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma","Perioperative Risk Factors and Nomograms for Participants With Hepatocellular Carcinoma Receiving Neoadjuvant Immunotherapy or Conversion Therapy","Inclusion Criteria:\n\nParticipants must meet all of the following conditions in order to be enrolled in this study:\n\n1. Voluntarily participate in this study and sign an informed consent form.\n2. Participants diagnosed with HCC through pathological histology\u002Fcytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).\n3. Received immunotherapy based neoadjuvant or conversion therapy.\n4. Complete recovery from surgical resection within 4 weeks prior to enrollment.\n5. Child Pugh liver function rating A or B (≤ 7 points).\n6. ECOG PS score was 0-1 points.\n7. Expected survival time ≥ 12 weeks.\n8. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor it; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to the diagnosis and treatment guidelines, and their liver function must be within CTCAE1 level elevation.\n\nExclusion Criteria:\n\nIf a subject meets any of the following conditions, they will not be allowed to enter this study:\n\n1. Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).\n2. There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).\n3. Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.\n4. Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or severe lung function impairment seen on chest computed tomography (CT) images during screening, are allowed to have radiation induced pneumonia in the radiation field; Active tuberculosis\n5. Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects that can be controlled only through hormone replacement therapy can be included\\]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require medical intervention with bronchodilators cannot be included.\n6. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) (based on the average BP reading obtained from ≥ 2 measurements), it is allowed to achieve the above parameters through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy.\n7. Participants with moderate to severe ascites with clinical symptoms who require therapeutic puncture or drainage, or whose Child Pugh score is greater than 7 (excluding those who only show a small amount of ascites on imaging but do not have clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.\n8. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA), level II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)\\\u003C50%; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year prior to the start of the research treatment; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc\\>480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken).\n9. History of spontaneous rupture of liver tumors.\n10. Individuals with a history of hepatic encephalopathy.\n11. Congenital or acquired immune dysfunction in subjects (such as HIV infected individuals).\n12. There have been incidents of thrombosis or embolism occurring within the first 6 months of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n13. Participants with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months prior to the start of the study treatment, such as those at risk of bleeding or severe esophageal and gastric varices, locally active gastrointestinal ulcer lesions, or continuous positive fecal occult blood, cannot be included in the study. (If fecal occult blood is positive during the baseline period, a follow-up examination is required. If the follow-up examination is still positive, gastroduodenoscopy (EGD) is required. If EGD indicates a risk of bleeding, esophageal and gastric varices\u002Fother gastrointestinal diseases cannot be included in the study.)\n14. Within 6 months prior to the start of treatment, there have been abdominal fistulas, gastrointestinal perforation, or abdominal abscesses.\n15. Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.\n16. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as in hemophilia participants; Currently or recently (within 10 days prior to the start of research treatment), full dose oral or injection anticoagulants or thrombolytic drugs (prophylactic use of low-dose aspirin, low molecular weight heparin allowed) have been used for therapeutic purposes.\n17. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occur within 6 months prior to the surgery.\n18. Severe infection within 4 weeks prior to the surgery, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of the study treatment (subjects who receive prophylactic antibiotics, such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease, are eligible to participate in the study).\n19. Use immunosuppressive agents or systemic hormone therapy within 14 days prior to the surgery to achieve immunosuppressive effects (dose\\>10mg\u002Fday prednisone or other therapeutic hormones).\n20. Received attenuated live vaccine treatment within 28 days prior to the surgery.\n21. According to the judgment of the researchers, the subjects may have other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious illnesses (including mental illness) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect the safety of the subjects.",{"count":465,"type":22},200,"This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant\u002Ftranslational treatment. A multi-dimensional and multi-method analysis plan will be adopted. The goal is to provide solutions for better application of neoadjuvant immunotherapy and to offer better evidence for conducting prospective clinical research on hepatocellular carcinoma.",[28,468],"Immunotherapy","2024-08-22",{"date":471,"type":41},"2024-08-26",{"date":473,"type":41},"2014-04-01",{"date":475,"type":22},"2026-08-03",{"name":477,"class":113},"Qilu Hospital of Shandong University",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":114},"100551014","phase-2-adjuvant-adebrelimab-plus-apatinib-for-participants-with-hcc-at-high-risk-of-recurrence-after-curative-resection-100551014","NCT06454578","Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection","An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of Adebrelimab Plus Apatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection","Inclusion Criteria:\n\nParticipants must meet all of the following conditions in order to be enrolled in this study:\n\n1. Voluntarily participate in this study and sign an informed consent form.\n2. Participants diagnosed with HCC through pathological histology\u002Fcytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).\n3. Within 4-12 weeks prior to enrollment, radical resection surgery was performed.\n4. Complete recovery from surgical resection within 4 weeks prior to enrollment.\n5. High risk factors for postoperative recurrence of hepatocellular carcinoma include multiple tumors, tumor length\\>5 cm, poor tumor differentiation (Edmondson III-IV grade), margin ≤ 1 cm, invasion of Microvasculature or large vessels, lymph node metastasis, sustained abnormalities in AFP or abnormal prothrombin , etc.\n6. Child Pugh liver function rating within 7 days prior to randomization: A or B (≤ 7 points).\n7. ECOG PS score within 7 days before randomization: 0-1 points.\n8. Have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past.\n9. Expected survival time ≥ 12 weeks.\n10. The main organ functions meet the following requirements (within 7 days before randomization):\n\n(1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction):\n\n• Neutrophil absolute count ≥ 1.5 × 109\u002FL; Platelets ≥ 75 × 10\\^9\u002FL; • Hemoglobin ≥ 90 g\u002FL.(Leukocyte and thrombocytopenia caused by splenic hyperfunction can be included in the group after partial embolization of the splenic artery or medication correction) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin ≥ 28g\u002FL; Total serum bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; Blood creatinine ≤ 1.5 x ULN or Cr clearance rate\\>50ml\u002Fmin (3) International standardized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the range of normal control ≤ 6 (4) Urinary protein\\\u003C2+(If urinary protein ≥ 2+, 24-hour urine protein quantification is required, and 24-hour urine protein quantification\\\u003C1.0g can be included in the group).\n\n11\\. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor it; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to the diagnosis and treatment guidelines, and their liver function must be within CTCAE1 level elevation.\n\n12.Women with fertility: must agree to contraception from the signing of the informed consent form until 90 days after the last use of the study drug (whichever is longer). And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactation period\n\nExclusion Criteria:\n\nIf a subject meets any of the following conditions, they will not be allowed to enter this study:\n\n1. Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma，and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).\n2. There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).\n3. Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), transarterial radiation embolization (TARE), etc.\n4. Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.\n5. Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, or other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or severe lung function impairment seen on chest computed tomography (CT) images during screening, are allowed to have radiation induced pneumonia in the radiation field; Active tuberculosis.\n6. Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects that can be controlled only through hormone replacement therapy can be included\\]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require medical intervention with bronchodilators cannot be included.\n7. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) (based on the average BP reading obtained from ≥ 2 measurements), it is allowed to achieve the above parameters through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy.\n8. Participants with moderate to severe ascites with clinical symptoms who require therapeutic puncture or drainage, or whose Child Pugh score is greater than 7 (excluding those who only show a small amount of ascites on imaging but do not have clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.\n9. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA), level II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)\\\u003C50%; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year prior to the start of the research treatment; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc\\>480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken).\n10. History of spontaneous rupture of liver tumors.\n11. Individuals with a history of hepatic encephalopathy.\n12. Congenital or acquired immune dysfunction in subjects (such as HIV infected individuals).\n13. There have been incidents of thrombosis or embolism occurring within the first 6 months of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n14. Participants with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months prior to the start of the study treatment, such as those at risk of bleeding or severe esophageal and gastric varices, locally active gastrointestinal ulcer lesions, or continuous positive fecal occult blood, cannot be included in the study. (If fecal occult blood is positive during the baseline period, a follow-up examination is required. If the follow-up examination is still positive, gastroduodenoscopy (EGD) is required. If EGD indicates a risk of bleeding, esophageal and gastric varices\u002Fother gastrointestinal diseases cannot be included in the study.)\n15. Within 6 months prior to the start of treatment, there have been abdominal fistulas, gastrointestinal perforation, or abdominal abscesses.\n16. Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.\n17. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as in hemophilia participants; Currently or recently (within 10 days prior to the start of research treatment), full dose oral or injection anticoagulants or thrombolytic drugs (prophylactic use of low-dose aspirin, low molecular weight heparin allowed) have been used for therapeutic purposes.\n18. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occur within 6 months prior to the start of the study treatment.\n19. Severe infection within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of the study treatment (subjects who receive prophylactic antibiotics, such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease, are eligible to participate in the study).\n20. It is known that the active ingredients and excipients contained in the investigational drugs (Adebelimumab, Apatinib) in this study have hypersensitivity reactions, or have a history of severe allergies to any other monoclonal antibodies or anti angiogenic targeted drugs.\n21. Use immunosuppressive agents or systemic hormone therapy within 14 days prior to the start of the study to achieve immunosuppressive effects (dose\\>10mg\u002Fday prednisone or other therapeutic hormones).\n22. Received attenuated live vaccine treatment within 28 days prior to the start of the study treatment, or expected to receive such vaccines during the treatment period with Adebrelimab or within 60 days after the last dose of Adebrelimab.\n23. Received other experimental drug treatments within 28 days or 5 half-lives (whichever is longer) prior to the start of the study treatment.\n24. According to the judgment of the researchers, the subjects may have other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious illnesses (including mental illness) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect the safety of the subjects.",{"count":486,"type":22},30,[61],"This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.",[28],"2024-07-30",{"date":492,"type":41},"2024-08-01",{"date":494,"type":41},"2024-07-24",{"date":496,"type":22},"2027-06",{"name":477,"class":113},{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":114},"100556874","phase-2-cryoablation-combined-with-pd-1-antibody-and-bevacizumab-for-hepatocellular-carcinoma-100556874","NCT06530784","Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma","Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1\u002FL1 Antibody Treatment: a Pilot Clinical Study","Inclusion Criteria:\n\n1. Age between 18 and 80 years old, and expected survival is longer than 3 months\n2. Clinically or pathologically diagnosed as primary hepatocellular carcinoma\n3. Disease progression assessed according to mRECIST criteria after PD-1\u002FL1 antibody treatment\n4. Child-Pugh score of liver function A\u002FB (\\\u003C 7)\n5. At least one lesion is suitable for mRECIST assessment\n6. Strength score (ECOG): 0-1\n7. The patient and\u002For family members agree to join the clinical trial and sign the informed consent form\n\nExclusion Criteria:\n\n1. Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon\n2. Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation\n3. Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10\\^4 before receiving treatment or do not continue to take antiviral drugs regularly\n4. Pregnant patients\n5. Combined with other malignant tumors, or have a history of other malignant tumors within 3 years\n6. Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication\n7. Severe renal dysfunction: creatinine (Cr) \\> 2 mg\u002FdL or creatinine clearance (CCr) \\\u003C30 mL\u002Fmin, severe heart, lung, brain and other important organ diseases\n8. History of gastrointestinal bleeding within 3 months\n9. Unable to cooperate with ablation surgery\n10. Severe gastroesophageal varices",{"count":506,"type":22},36,[61],"To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1\u002FL1 antibody.",[28],"2024-07-26",{"date":512,"type":41},"2024-07-31",{"date":512,"type":22},{"date":515,"type":22},"2026-05-31",{"name":112,"class":113},{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":114},"100520767","liver-resection-and-simultaneous-sleeve-gastrectomy-for-ms-hcc-liress-100520767","NCT06060847","Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)","Liver Resection and Simultaneous Sleeve Gastrectomy for HCC Related to Metabolic Syndrome (LIRESS)","LIRESS","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent\u002Fassent for the trial\n2. Be ≥ 18 years of age on day of signing informed consent.\n3. Have hepatocellular carcinoma with metabolic syndrome as unique risk factor\n4. Have an overall Child-Pugh score = A\n5. Be eligible for liver resection with laparoscopic or robotic technique\n6. Be eligible for bariatric surgery as defined below\n\n   * BMI ≥ 40 kg\u002Fm2\n   * BMI ≥ 35-40 kg\u002Fm2 with associated comorbidities\n   * BMI 30-35 kg\u002Fm2 and type 2 diabetes\n   * BMI 30-35 kg\u002Fm2 and arterial hypertension with poor control despite optimal medical therapy.\n\nExclusion Criteria:\n\n1. Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome\n2. Denial of the patient to undergo bariatric procedure\n3. Have BMI \\\u003C 30\n4. Have negative opinion of psychologic consultant\n5. Have an overall Child-Pugh score \\> 7\n6. Evidence of clinical significant portal hypertension as followed:\n\n   * esophageal varices\n   * gastric varices\n   * portal hypertensive gastropathy\n   * gastric vascular ectasia\n\nOf note: 1) Conversion to open surgery for any reason does not represent a reason of data exclusion from the analysis; 2) any type of hepatic resection, according to Brisbane classification, is included, also major hepatectomy requiring preoperative intervention to achieve adequate volume remnant",{"count":320,"type":22},[25],"Hepatocellular carcinoma (HCC) related to metabolic syndrome (MS) as unique risk factor is gradually overpassing the more common viral and alcohol etiology, becoming a global health issue. Liver surgery for metabolic syndrome-related HCC in this frail subset of patients constitute a challenge, due to high morbidity and mortality rate reported in literature, and contrasting results in term of oncologic outcome. The present multicentric prospective study aims to ascertain if the combination of sleeve gastrectomy and liver surgery in the same surgical procedure may have benefit in terms of reduced perioperative morbidity and prolonged Overall Survival and Recurrence Free Survival. Secondary outcome will be the evaluation of the consequences induced by sleeve gastrectomy on liver disease, in particular liver fibrosis evaluated in term of NFS score (Non-Alcoholic Fatty Liver Disease Fibrosis score), FIB-4 (Fibrosis-4 Index for Liver Fibrosis) score and Fibroscan transient elastography.",[28,529],"Metabolic Syndrome",[531,532,533],"hepatocellular carcinoma","sleeve gastrectomy","morbid obesity","2023-12-18",{"date":536,"type":41},"2023-12-19",{"date":538,"type":22},"2024-03-06",{"date":540,"type":22},"2032-03-06",{"name":542,"class":113},"Ospedale V. Fazzi",{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":17,"minAge":550,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":114},"100529835","effects-of-cognitive-intervention-therapy-on-postoperative-delirium-100529835","NCT06178939","Effects of Cognitive Intervention Therapy on Postoperative Delirium","Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients","Inclusion Criteria:\n\n* Elderly patients aged 65 and above.\n* Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.\n* Patients scheduled for arterial catheterization.\n\nExclusion Criteria:\n\n* Patients with uncontrolled systemic conditions such as diabetes and hypertension.\n* Those with visual impairment.\n* Patients with cognitive impairment based on the MMSE-DS criteria.\n* Individuals experiencing difficulty in communication.\n* Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).\n* Patients diagnosed with alcohol or substance addiction.","65 Years",{"count":552,"type":22},60,[25],"This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.",[556,557,558,28],"Spinal Stenosis","Disc Herniation","Lung Neoplasms","2023-12-15",{"date":561,"type":41},"2023-12-21",{"date":563,"type":22},"2023-12",{"date":565,"type":22},"2027-10",{"name":567,"class":113},"Yonsei University",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":576,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":114},"100506175","digitalized-surveillance-management-for-liver-cancer-risk-population-in-improving-eearly-diagnosis-efficancy-in-chinese-population-dsearch-100506175","NCT05870969","Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)","Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China","dSEARCH","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures\\[17\\]\n2. Age: 18 to 75 years old (including the cut-offs)\n3. Subjects must meet at least one of the following criteria for enrollment.\n\n   1. Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more\n   2. Patients diagnosed with hepatitis C in hospital or out of hospital\n   3. Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.\n\n      1. Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);\n      2. Liver stiffness measurement (LSM) using FibroScan® (Echosens™, Paris, France) ≥12.0 kPa when TB was normal and ALT ≤ 40 IU\u002FmL, or LSM ≥ 17.0 kPa when TB was normal and ALT \\\u003C 200 IU\u002FmL;\n      3. Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);\n      4. APRI ≥ 2.0;\n      5. FIB-4 ≥ 3.25\n   4. Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold\\[18\\].\n\n      * MAFLD diagnosis requires diagnosis of \\>5% fat accumulation in liver through either FibroScan® CAP measurements, or similar parameter, or liver biopsy, and in combination with one of the following three conditions: overweight\u002Fobesity (BMI \\>23 kg\u002Fm2), type 2 diabetes, or metabolic dysfunction.\n   5. Patients diagnosed with MAFLD combined with abnormal glucose metabolism\\[19\\]\n\n      * Abnormal glucose metabolism is defined as type 2 diabetes, or prediabetes, i.e. fasting blood glucose 5.6-6.9 mmol\u002FL, or 2h postprandial blood glucose 7.8-11.0 mmol\u002FL, or glycated hemoglobin 5.7%-6.4%\n   6. Subjects with a family history of liver cancer in their first-degree biological relatives.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n1. Age \\\u003C18 years or \\>75 years\n2. Patients who have been diagnosed with liver cancer before enrollment\n3. Patients with severe mental illness or cognitive impairment\n4. Patients who are pregnant or lactating, or preparing to become pregnant\n5. Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment\n6. According to the doctor's judgment, the possibility of the subject being included is low (including inability to understand the project requirements , poor compliance, infirmity, inability to ensure that the protocol can be implemented as required, etc.), or the doctor determines that the subject has any other factors that are not suitable for this study",{"count":577,"type":22},20000,"The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.",[28,580,581,582,583],"Hepatitis C, Chronic","Hepatitis B, Chronic","Cirrhosis, Liver","Non-Alcoholic Fatty Liver Disease","2023-05-13",{"date":586,"type":41},"2023-05-23",{"date":588,"type":41},"2023-03-01",{"date":590,"type":22},"2028-03",{"name":592,"class":113},"Ruijin Hospital",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":237},"100354639","phase-1-abx196-in-combination-with-nivolumab-in-patients-with-hepatocellular-carcinoma-100354639","NCT03897543","ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Men or women, Age ≥18 years\n* Patients with ECOG performance status 0 or 1\n* Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy\n* Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent\n* Patients with at least one prior systemic therapy for HCC\n* Patients eligible to be treated with nivolumab\n* Patients with measurable disease based on RECIST v1.1\n* Patients with Child-Pugh class A liver score within 7 days of first study dose\n* Patients with no history of hepatic encephalopathy\n* Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)\n* Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \\\u003C100 IU\u002FmL within 7 days of first study dose\n* Patients with no active co-infection with HBV and HCV or HBV and HDV\n* Patients with no active drug or alcohol abuse\n\nExclusion Criteria:\n\n* Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose\n* Patients with esophageal or gastric variceal bleeding within the past 6 months\n* Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging\n* Patients with previous solid organ or hematologic transplantation\n* Patients with active autoimmune disease requiring systemic treatment in the past 2 years\n* Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose\n* Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose\n* Patients with minor surgery to liver or another site within 1 week before first study dose",{"count":601,"type":22},48,[60,61],"Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma",[28],[606,404,607],"HCC","ABX196","2021-03-25",{"date":610,"type":41},"2021-03-26",{"date":612,"type":41},"2019-08-30",{"date":614,"type":22},"2023-06-30",{"name":616,"class":81},"Abivax S.A.",{"id":618,"slug":619,"hasResults":11,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100268864","phase-4-oral-vitamin-d-treatment-for-the-prevention-of-hepatocellular-carcinoma-100268864","NCT02779465","Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma","Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B","VDHCC","Inclusion Criteria:\n\n* All subjects between the ages of 18 and 70 with chronic hepatitis B and under the oral anti-virus treatment followed at the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, will be offered entry into this study. The diagnosis of chronic Hepatitis B will be based on that they had been positive for hepatitis B surface antigen (HBsAg) for at least six months, and were positive for HBeAg or negative for HBeAg with detectable HBV DNA at screening.\n* No evidence of HCC on entry imaging study.\n* Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).\n* Not currently participating in another intervention study.\n* Not pregnant or lactating, and willing to use effective contraception during study period.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Ability to provide written informed consent according to national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* evidence of hepatocellular carcinoma within 6 months after enrollment,\n* a serum alanine aminotransferase level more than 10 times the upper limit of normal,\n* an elevated serum creatinine level,\n* any diagnosis of kidney stones,\n* a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,\n* any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,\n* other serious concurrent illness (e.g., alcoholism, uncontrolled diabetes, or cancer),\n* treatment with immunomodulatory within the 6 months before screening,\n* treatment with any investigational drug within the 30 days before the study began.","70 Years",{"count":627,"type":22},1500,[270],"The purpose of this study is to determine whether vitamin D is effective in the prevention of hepatocellular carcinoma in those patients with chronic hepatitis B.",[275,28],[632,633],"vitamin D treatment","chronic hepatitis B","2016-05-19",{"date":636,"type":22},"2016-05-20",{"date":638,"type":4},"2016-06",{"date":640,"type":22},"2026-12",{"name":642,"class":113},"Third Affiliated Hospital, Sun Yat-Sen University"]