[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lenvatinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lenvatinib":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,72,100,131,154,178,208,230,251,274,292,315],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100625066","construction-and-clinical-validation-of-a-predictive-model-for-postoperative-adjuvant-therapy-in-hepatocellular-carcinoma-based-on-whole-slide-digital-pathological-images-and-deep-learning-100625066",false,"NCT07417800","Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning","Inclusion Criteria:\n\n* Histopathologically confirmed hepatocellular carcinoma;\n* Aged more than 18 years;\n* Underwent radical resection of primary liver cancer (R0 resection);\n* Availability of postoperative H\\&E-stained paraffin embedded tissue sections suitable for digital whole-slide imaging;\n* Had complete and accessible clinicopathological data and follow-up data;\n* Has complete and evaluable preoperative and postoperative contrast-enhanced CT or MRI imaging with standardized scanning parameters and no severe artifacts, meeting the quality requirements for radiomic and artificial intelligence analysis.\n\nExclusion Criteria:\n\n* Significant missing clinical or follow-up data;\n* Concurrent primary malignancy in other organs;\n* Positive surgical margin (R1 or R2 resection);\n* Tissue sections of poor quality (e.g., severe fading, folding, damage) unsuitable for digital scanning or analysis;","ALL","18 Years",{"count":18,"type":19},11000,"ESTIMATED","OBSERVATIONAL","Hepatocellular carcinoma (HCC) is a high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources.\n\nTumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence.\n\nThis study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT\u002FMRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies.\n\nThis is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients will be prospectively and consecutively enrolled from 10-15 centers. The AI model will generate adjuvant therapy predictions without interfering with real clinical decisions. Patients will be divided into prediction-consistent and prediction-inconsistent cohorts based on the match between model predictions and actual treatments. Long-term follow-up will be performed to compare prognostic outcomes and validate the model's real-world performance and stability.\n\nKey inclusion criteria: histopathologically confirmed HCC; aged 18-75 years; received R0 curative resection; available qualified H\\&E-stained FFPE slides for digital scanning; complete clinical, pathological and follow-up data; high-quality preoperative contrast-enhanced CT\u002FMRI images eligible for AI analysis. Key exclusion criteria: prior preoperative anti-tumor therapy with unavailable baseline data; concurrent other primary malignancies; non-R0 resection; unqualified pathological slides or imaging data; severe missing clinical or follow-up information.",[23,24,25,26,27,28],"Hepatocellular Carcinoma (HCC)","Artificial Intelligent","Adjuvant Chemoradiotherapy","TACE","Lenvatinib","Liver Surgery",[23,24,26,30,25],"lenvatinib","RECRUITING","2026-06-07",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2025-11-01",{"date":39,"type":19},"2029-12-01",{"name":41,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"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.","19 Years",{"count":54,"type":19},24,"INTERVENTIONAL",[57],"PHASE2","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",[60,27,61],"Carcinoma, Hepatocellular","Treatment Failure","NOT_YET_RECRUITING","2026-03-30",{"date":65,"type":35},"2026-04-07",{"date":67,"type":19},"2026-03-15",{"date":69,"type":19},"2028-06-30",{"name":71,"class":42},"Ju Hyun Shim",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":55,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100605184","phase-2-disitamab-vedotin-plus-lenvatinib-and-pd-1-inhibitors-for-treating-her2-positive-advanced-biliary-tract-cancer-100605184","NCT07159217","Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer","A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer","Inclusion criteria:\n\n1. Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.\n2. Age ≥ 18 years and any gender.\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).\n4. At least one measurable lesion (according to RECIST 1.1).\n5. ECOG performance status score of 0-1.\n6. Child-Pugh score ≤ 7 .\n7. HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2\u002FCEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.\n8. No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.\n9. Expected survival \\> 12 weeks.\n10. Adequate hematological and major organ function.\n\nExclusion criteria：\n\n1. Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.\n2. Pregnant women (positive pregnancy test before medication) or lactating women.\n3. Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.\n4. History of other active malignancies within 5 years prior to screening.\n5. Presence of central nervous system metastasis and\u002For leptomeningeal metastasis.\n6. Unhealed severe wounds, active ulcers, or untreated fractures.\n7. Administration of live vaccines within 30 days prior to randomization.\n8. Active autoimmune disease or history of autoimmune disease.\n9. Presence of clinically significant gastrointestinal disorders.\n10. Presence of clinically significant cardiovascular or cerebrovascular diseases.",{"count":80,"type":19},65,[57],"This trial is a single-arm exploratory phase II clinical study initiated by the investigator.\n\nSubjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.",[84,85,27,86],"Biliary Tract Cancer","Disitamab Vedotin","Immune Checkpoint Inhibitors",[88,89,27,90],"Biliary tract cancer","Disitamab vedotin","Immune checkpoint inhibitors","2025-08-28",{"date":93,"type":35},"2025-09-08",{"date":95,"type":19},"2025-08-30",{"date":97,"type":19},"2028-05-31",{"name":99,"class":42},"Peking Union Medical College Hospital",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":55,"phases":110,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":43},"100572984","tace-combined-with-lenvatinib-and-pd-1-inhibitor-for-ruptured-hepatocellular-carcinoma-100572984","NCT06740370","TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma","TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;\n2. presence of hemostasis in the enhanced CT scan;\n3. integrity of the tumor is disrupted and there is hematoma around the liver;\n4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;\n5. transarterial artery chemoembolization (TACE) as local therapy;\n6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;\n7. no history of other malignancies.\n8. life expectancy more than 3 months;\n9. agreed to participated in this clinical trial;\n10. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. recurrent HCC;\n2. non-ruptured HCC;\n3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;\n4. age \\\u003C 18 years or \\> 75 years;\n5. HCC with more than five metastases;\n6. History of hepatic encephalopathy and gastrointestinal bleeding\n7. life expectancy less than 3 months.","75 Years",{"count":109,"type":19},32,[111],"NA","Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.",[114,115,116,27],"Hepatocellular Carcinoma","Transcatheter Arterial Chemoembolization","Anti-PD1 Antibody",[118,26,27,119,120,121],"ruptured hepatocellular carcinoma","Tislelizumab","Sintilimab","Camrelizumab","2025-08-10",{"date":124,"type":35},"2025-08-14",{"date":126,"type":35},"2024-12-13",{"date":128,"type":19},"2026-08-30",{"name":130,"class":42},"Sun Yat-sen University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":138,"targetDuration":4,"studyType":55,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100510009","phase-2-lenvatinib-combined-with-tislelizumab-and-tace-applied-as-neoadjuvant-regimen-for-the-patients-of-cnlc-stage-ib-and-iia-hepatocellular-carcinoma-with-high-risk-recurrence-factors-100510009","NCT05920863","Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors","Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High Risk of Recurrence: Study Protocol of a Monocenter, Single-arm, Open Label Clincal Trail","Inclusion Criteria:\n\n1. Aged 18-75 years old (inclusive);\n2. HCC is confirmed by preoperative pathological examination or meet the criterion of diagnosis and treatment norms of primary HCC issued by health commission, PRC. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;\n3. Patients with CNLC IB or IIA stage tumors before surgery and meeting the following conditions: radiological evaluation shows narrow or none surgical margins, and preoperative tumor markers AFP+PIVKA is greater than 1600.\n4. ECOG score of 0 before the first administration of the study drug;\n5. Child-Pugh scores is 5-6 points and liver function is grade A;\n6. Expected survival time of at least 16 weeks;\n7. Pre-administration organ function levels meet the requirements and are tolerant of surgery. The functional indicators of important organs meet the following requirements: hemoglobin ≥90g\u002FL, neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL; aspartate aminotransferase or alanine aminotransferase ≤5 times the upper limit of normal (ULN), alkaline phosphatase ≤2.5 ULN, serum albumin ≥30g\u002FL; serum creatinine \\\u003C1.5 ULN; international normalized ratio (INR) ≤2 or prothrombin time (PT) within the upper limit of normal range ≤6 seconds; serum creatinine ≤1.5 ULN, creatinine clearance rate ≥60 mL\u002Fmin.\n8. Male and female participants of childbearing potential must agree to use effective contraception throughout the study period;\n9. Sign an informed consent form and agree to provide previously stored tumor tissue specimens or fresh biopsy specimens of the tumor lesion.\n\nExclusion Criteria:\n\n1. Pathologically diagnosed as non-hepatocellular carcinoma;\n2. Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy);\n3. CNLC stage is IA, IIB or worse.\n4. Viral load limited to hepatitis B virus (HBV) DNA\\>2000 copies\u002Fml, hepatitis C virus (HCV) RNA\\>1000;\n5. Long-term steroid users who require long-term systemic steroid therapy (equivalent to \\>10 mg of prednisone per day) or any other form of immunosuppressive treatment;\n6. Significant clinical bleeding or bleeding tendency within 3 months before enrollment or currently undergoing thrombolysis or anticoagulation treatment;\n7. Complete intestinal obstruction and incomplete intestinal obstruction requiring treatment, but patients who have had obstruction relieved by fistula or stent placement can be enrolled;\n8. Active severe clinical infection (\\> grade 2, NCI-CTCAE version 5.0), including active tuberculosis; history of active tuberculosis infection for more than 1 year before enrollment, not treated with regular anti-tuberculosis treatment or tuberculosis still in the active period; active known or suspected autoimmune disease;\n9. Uncontrolled diabetes (fasting blood glucose ≥10 mmol\u002FL), severe lung disease (such as acute pulmonary disease, pulmonary fibrosis that affects lung function, interstitial lung disease. Excluding recovered radiation pneumonitis);\n10. Clinically significant cardiovascular disease; hypertension which cannot be well controlled by anti-hypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);\n11. Patients undergoing renal replacement therapy;\n12. History of other malignant tumors within the past 5 years. Excluding cured basal cell carcinoma or cervical intraepithelial neoplasia;\n13. Other patients who are expected to be unable to tolerate surgical treatment;\n14. Patients who have had allergic reactions to any component of the study drug;\n15. Presence of alcohol dependence, mental illness, pregnancy (or lactation) or other conditions that are not suitable for clinical trials.",{"count":139,"type":19},35,[57],"This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)",[114,27,119,26,143,144],"Pharmorubicin","Oxaliplatin","2025-02-09",{"date":147,"type":35},"2025-02-11",{"date":149,"type":35},"2023-07-01",{"date":151,"type":19},"2025-12-31",{"name":153,"class":42},"Zhejiang Cancer Hospital",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":161,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":43},"100541722","haic-combined-with-lenvatinib-and-pd-1-inhibitor-in-infiltrative-hepatocellular-carcinoma-100541722","NCT06333561","HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma","Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study","Inclusion Criteria:\n\n1. primary infiltrative HCC according to MRI or CT imaging characteristics.\n2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n3. Lenvatinib as initial treatment.\n4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.\n5. no history of other malignancies.\n6. no tumor thrombus in the atrium or vena cava.\n\nExclusion Criteria:\n\n1. HCC with tumor capsule.\n2. under 18 years or over 75 years.\n3. TACE as initial treatment.\n4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.\n5. incomplete tumor imaging data.\n6. lost to follow-up after treatment within three months.",{"count":162,"type":19},300,"Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.",[114,27,165,166],"PD-1 Inhibitor","Hepatic Arterial Infusion Chemotherapy",[168,119,169,120,121,27],"Hepatic arterial infusion chemotherapy","Toripalimab","2025-02-05",{"date":172,"type":35},"2025-02-06",{"date":174,"type":35},"2021-01-01",{"date":176,"type":19},"2025-12-30",{"name":130,"class":42},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":185,"targetDuration":4,"studyType":55,"phases":187,"briefSummary":188,"conditions":189,"keywords":194,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":43},"100562952","the-comparison-of-tace-lenvatinib-with-tace-lenvatinib-ablation-for-intermediate-recurrent-hepatocellular-carcinoma-100562952","NCT06609850","The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma","The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study","Inclusion Criteria:\n\n1. 18-75 years;\n2. RHCC diagnosed by imaging;\n3. intermediate-stage RHCC (two to three lesions which at least one was \\>3 cm in size or more than three tumors);\n4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;\n5. absence of extrahepatic metastasis or macrovascular invasion;\n6. Child-Pugh class A or B;\n7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.\n8. life expectance \\>3 months;\n\nExclusion Criteria:\n\n1. under 18 years or over 75 years of age;\n2. primary intermediate-stage HCC;\n3. RHCC with more than six tumors, or single RHCC\n\n(5) RHCC \\>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;",{"count":186,"type":19},116,[111],"Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.",[190,27,191,192,193],"Recurrent Hepatocellular Carcinoma","Local Therapy","Ablation","Systemic Therapy",[195,196,197,198,199],"Lenvatinb","Hepatocellular carcinoma","Microwave ablation","Radiofrequency ablation","Cryoablation","2024-12-01",{"date":202,"type":35},"2024-12-03",{"date":204,"type":35},"2024-10-01",{"date":206,"type":19},"2028-10-30",{"name":130,"class":42},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":215,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":43},"100564662","haic-in-combination-with-pd-1-inhibitors-and-lenvatinib-for-intermediate-and-advanced-hcc-after-the-failure-of-systemic-therapy-recommended-by-bclc-100564662","NCT06632093","HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC","Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC","Inclusion Criteria:\n\n1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;\n3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;\n4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;\n5. HAIC was performed after the first PD-1 inhibitor\u002F Lenvatinib treatment or before treatment;\n6. Received at least 2 cycles of HAIC；\n7. Has repeated measurable intrahepatic lesions;\n8. Child-Pugh class A or B.\n\nExclusion Criteria:\n\n1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;\n2. With other malignant tumors;\n3. Unable to meet criteria of combination timeframe described above.",{"count":216,"type":19},84,"The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.",[219,220,166,27,221,193],"BCLC Stage B Hepatocellular Carcinoma","BCLC Stage C Hepatocellular Carcinoma","PD-1","2024-10-06",{"date":224,"type":35},"2024-10-08",{"date":226,"type":35},"2024-09-16",{"date":176,"type":19},{"name":229,"class":42},"First Hospital of China Medical University",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":237,"targetDuration":4,"studyType":55,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":43},"100520800","btae-haic-combined-with-system-therapy-for-intermediate-advanced-huge-hcc-100520800","NCT06061276","bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC","Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Clinical diagnosis of HCC.\n2. Age between 18 and 75 years;\n3. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;\n4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).\n5. Child-Pugh class A or B;\n6. Eastern Cooperative Group performance status (ECOG) score of 0-2;\n7. Hemoglobin ≥ 8.5 g\u002FdL Total bilirubin ≤ 30mmol\u002FL Serum albumin ≥ 32 g\u002FL ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT\u002FAPTT within normal limits Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n8. Prothrombin time ≤18s or international normalized ratio \\\u003C 1.7.\n9. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Diffuse HCC;\n2. Extrahepatic metastasis \\>5;\n3. Obstructive PVTT involving the main portal vein.\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. Known history of HIV\n7. History of organ allograft\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.",{"count":238,"type":19},40,[111],"This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.",[242,114,243,121,27],"Liver Diseases","Immunotherapy","2024-09-20",{"date":246,"type":35},"2024-09-23",{"date":248,"type":35},"2024-05-20",{"date":176,"type":19},{"name":130,"class":42},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":258,"targetDuration":4,"studyType":55,"phases":260,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":43},"100558423","ablation-of-oligometastasis-combined-with-lenvatinib-and-pd-1-inhibitor-for-advanced-hepatocellular-carcinoma-100558423","NCT06550921","Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma","Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20;\n2. presence of oligometastasis, the metastases found within three month of HCC diagnosis;\n3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;\n4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);\n5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC);\n6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. no history of other malignancies.\n8. life expectancy more than 3 months;\n9. agreed to participated in this clinical trial;\n10. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. recurrent HCC;\n2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;\n3. age \\\u003C 18 years or \\> 75 years;\n4. advanced HCC with more than five metastases;\n5. no response to Lenvatinib;\n6. metastases size \\> 5 cm;\n7. life expectancy less than 3 months.",{"count":259,"type":19},60,[111],"Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.",[263,264,192,116,27],"Advanced Hepatocellular Carcinoma","Oligometastasis",[195,119,120,121],"2024-08-08",{"date":268,"type":35},"2024-08-13",{"date":270,"type":35},"2024-08-01",{"date":272,"type":19},"2027-08-30",{"name":130,"class":42},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":281,"targetDuration":4,"studyType":55,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":43},"100521518","btae-haic-combined-with-lenvatinib-and-sintilimab-for-infiltrative-hepatocellular-carcinoma-100521518","NCT06070636","bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma","Sequential bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Diagnosis of infiltrative HCC.\n2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin\n3. Age between 18 and 75 years;\n4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;\n5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).\n6. Child-Pugh class A or B;\n7. Eastern Cooperative Group performance status (ECOG) score of 0-2;\n8. Hemoglobin ≥ 8.5 g\u002FdL Total bilirubin ≤ 30mmol\u002FL Serum albumin ≥ 32 g\u002FL ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT\u002FAPTT within normal limits Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n9. Prothrombin time ≤18s or international normalized ratio \\\u003C 1.7.\n10. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. HCC with capsule;\n2. Extrahepatic metastasis \\>5;\n3. Obstructive PVTT involving the main portal vein.\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. Known history of HIV\n7. History of organ allograft\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.",{"count":282,"type":19},30,[111],"This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.",[242,114,243,27,120],{"date":287,"type":35},"2024-08-09",{"date":248,"type":35},{"date":290,"type":19},"2025-06-30",{"name":130,"class":42},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":107,"enrollmentInfo":299,"targetDuration":4,"studyType":55,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":43},"100473406","microwave-ablation-simultaneously-combined-with-lenavatinib-for-recurrent-hepatocellular-carcinoma-100473406","NCT05444478","Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma","Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study","Inclusion Criteria:\n\n1. Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；\n2. recurrent HCC without any tumor related therapy；\n3. Tumor number ≤3；\n4. Tumor size ≤5cm;\n5. Good performance, KPS≥90；\n6. Age：18-75\n7. Child-Pugh A or B（score of the B level is no more than 7）\n8. Baseline laboratory examinations meet the Criteria： Leukocyte ≥3.0×109\u002FL； Blood platelet ≥75×109\u002FL； Hemoglobin ≥100g\u002FL； ALT、AST ≤ 3 x limit of normal（ULN）； Serum creatinine ≤ 1.5 x ULN； Prothrombin time \\\u003C ULN+4 s；INR \\\u003C 1.5, Albumin ≥30g\u002FL ； Total bilirubin ≤34mmol\u002FL；\n\nExclusion Criteria:\n\n1. disagreeing to receive follow-up observation and participate the clinical study;\n2. Accompanying with a history of other malignancies;\n3. Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;\n4. with extrahepatic metastasis or lymph metastasis;\n5. receiving system therapy such as targeted therapy or immunotherapy;\n6. receiving local therapy such as ablation or TACE;\n7. Any of the following occurred within 12 months of the study: myocardial infarction, severe \u002F unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing arrhythmia by NCI-CTCA standard ≥ 2, prolonged QTc interval (450 ms for males, and\\> 470 ms for females;\n8. other serious acute, chronic physiological or mental disorders or abnormal laboratory examination may increase the risk of participation in study treatment or may interfere with the interpretation of study findings or whom the investigator considers not fit;",{"count":300,"type":19},274,[111],"This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC",[114,304,305,27,306],"Microwave Ablation","Liver Cancer","Recurrent Tumor","2023-11-05",{"date":309,"type":35},"2023-11-07",{"date":311,"type":35},"2022-07-01",{"date":313,"type":19},"2027-07-01",{"name":130,"class":42},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":15,"minAge":322,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":55,"phases":325,"briefSummary":327,"conditions":328,"keywords":332,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":43},"100461260","phase-1-phase-ibii-trial-of-combining-pembrolizumab-and-lenvatinib-with-sbrt-for-hcc-patients-with-portal-vein-thrombosis-100461260","NCT05286320","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.","Phase Ib\u002FII Trial of Combining Pembrolizumab and Lenvatinib With Stereotactic Body Radiotherapy for Hepatocellular Carcinoma Patients With Portal Vein Thrombosis.","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed diagnosis of HCC or those diagnosed by the EASL non-invasive criteria for HCC will be enrolled in this study.\n2. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.\n3. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Have measurable disease based on mRECIST.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n7. Have adequate organ function as defined in the following criteria (Specimens must be collected within 10 days prior to the start of study intervention) :(1)Absolute neutrophil count (ANC) ≥1500\u002FµL. (2)Platelets ≥100000\u002FµL. (3)Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL. (4)Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN. (5)Total bilirubin ≤1.5 ×ULN (mg\u002FdL) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>2.5 × ULN (mg\u002FdL).(6)AST (SGOT) and ALT (SGPT) ≤5 × ULN. (7)Alkaline phosphatase ≤2 × ULN.(8)Child-Pugh class Class A. (9)International normalized ratio (INR) OR prothrombin time (PT)、Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n8. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to starting study intervention. Participants with HBV will be eligible as long as they meet the following criteria: (1) Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to starting study intervention. (2)Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n9. Patients have PVTT in the main trunk (VP4) or central branch (VP3).\n10. Previous liver resection, embolization, or ablative therapy is permitted.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to \\[allocation\\]. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-HCC therapy including investigational agents or other local therapy within 4 weeks prior to \\[allocation\\].\n4. Has received prior radiotherapy to non-liver sites within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive or modulation therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab\u002FLenvatinib and\u002For any of their excipients.\n10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n12. Has an active infection requiring systemic therapy.\n13. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n17. Has had an allogenic tissue\u002Fsolid organ transplant.\n18. Child-Pugh class B or C cirrhosis of liver.\n19. Patients with a history of selective internal radiation therapy (eg, microsphere radioembolization) or who have received radiotherapy to the abdominal area prior to the initiation of study treatment.\n20. Patients who have an inadequate hepatic reserve, as judged by the investigator; ie, normal liver tissue volume \\\u003C700 mL.\n21. Patients who fail to follow the radiation dose constraint of any critical organ.\n22. Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n23. Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study intervention.\n24. Has significant cardiovascular impairment within 12 months prior to the first dose of study intervention such as history of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability.\n25. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.\n\n    Note: f participant underwent major surgery, they must have adequately recovered from the toxicity and\u002For complications from the intervention prior to starting study intervention.\n26. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1).\n27. Has serious nonhealing wound, ulcer, or bone fracture.\n28. Participants with proteinuria \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g\u002F24 hours will be ineligible.\n29. Has prolongation of corrected QT (QTc) interval to \\>480 ms (corrected by Fridericia Formula) or is taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics (Quinidine, Procainamide, Disopyramide, Amiodarone, Sotalol, Ibutilide, Dofetilide \\& Dronedarone).\n30. Has LVEF below the institutional normal range as determined by MUGA or echocardiogram (ECHO).\n31. Has dual active HBV infection (HbsAg positive and \u002For detectable HBV DNA) and HCV infection (anti-HCV Ab positive and detectable HCV RNA) at study entry.\n32. Uncontrolled blood pressure \\> 140\u002F90 mmHg in spite of an optimal regimen of antihypertensive medication.","20 Years",{"count":324,"type":19},27,[326,57],"PHASE1","HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.",[329,330,27,331],"Unresectable Hepatocellular Carcinoma","Pembrolizumab","Stereotactic Body Radiotherapy",[329,243,333,334],"Stereotactic body radiotherapy","targeted therapy","2023-02-28",{"date":337,"type":35},"2023-03-02",{"date":339,"type":19},"2023-03-01",{"date":341,"type":19},"2026-09-30",{"name":343,"class":42},"National Taiwan University Hospital"]