[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656707":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":59,"studyPopulation":55,"armGroups":60,"interventions":68,"overallOfficials":55,"centralContacts":81,"locations":55,"responsibleParty":87,"collaborators":55,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":55,"enrollmentInfo":98,"targetDuration":55,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":112,"whyStopped":55,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":55},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"1-year progression-free survival (PFS) by mRECIST","Percentage of participants alive and free of disease progression at 1 year. Progression-free survival is measured from the start date of study treatment to the date of first documented disease progression according to modified RECIST (mRECIST) or death from any cause, whichever occurs first.","1 year after start of study treatment",[14,17,21,24,27,30,33,37],{"measure":15,"description":16,"timeFrame":12},"1-year overall survival (OS)","Percentage of participants alive at 1 year. Overall survival is measured from the start date of study treatment to the date of death from any cause.",{"measure":18,"description":19,"timeFrame":20},"Objective response rate (ORR) by mRECIST","Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by modified RECIST (mRECIST). Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.","Up to 12 months after start of study treatment",{"measure":22,"description":23,"timeFrame":20},"Objective response rate (ORR) by RECIST v1.1","Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by RECIST version 1.1. Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.",{"measure":25,"description":26,"timeFrame":20},"Disease control rate (DCR) by mRECIST","Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by modified RECIST (mRECIST). Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.",{"measure":28,"description":29,"timeFrame":20},"Disease control rate (DCR) by RECIST v1.1","Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by RECIST version 1.1. Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.",{"measure":31,"description":32,"timeFrame":20},"Duration of response (DOR) by mRECIST","Time from the date of first documented objective response (complete or partial response) to the date of first documented disease progression, as assessed by modified RECIST (mRECIST). Reported in months.",{"measure":34,"description":35,"timeFrame":36},"Incidence of hepatic decompensation","Percentage of participants with hepatic decompensation within 30 days after treatment. Hepatic decompensation is defined as any of the following: total bilirubin greater than 3 mg\u002FdL, new or worsened ascites, or hepatic encephalopathy.","Within 30 days after treatment",{"measure":38,"description":39,"timeFrame":40},"Incidence of treatment-emergent adverse events","Number of participants with treatment-emergent adverse events and serious adverse events, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.","From first dose of study treatment up to 30 days after the last dose",[42,45,49],{"measure":43,"description":44,"timeFrame":20},"Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)","Maximum percentage reduction from baseline in the sum of viable target lesion diameters, as assessed by modified RECIST (mRECIST). Reported as percentage change from baseline.",{"measure":46,"description":47,"timeFrame":48},"Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry","Change from baseline in the frequencies of peripheral blood immune cell subsets measured by multiparametric flow cytometry, including CD4+ and CD8+ T cells, regulatory T cells, natural killer cells, mucosal-associated invariant T cells, and myeloid populations, together with the activation and exhaustion markers PD-1, TIM-3, HLA-DR, and CD38. Reported as percentage of live cells.","Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24",{"measure":50,"description":51,"timeFrame":48},"Change from baseline in immune cell composition assessed by single-cell RNA sequencing","Change from baseline in immune cell composition measured by single-cell RNA sequencing of peripheral blood mononuclear cells and tissue samples, reported as percentage of sequenced cells assigned to each annotated immune cell cluster.",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":55,"timePerspective":55,"maskingInfo":57},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":58,"maskingDescription":55,"whoMasked":55},"NONE","Primary objective:\n\n-1-year progression-free survival (PFS) by mRECIST\n\nSecondary objectives:\n\n* 1-year overall survival (OS)\n* Objective response rate (ORR) and disease control rate (DCR) per RECIST v1.1 and mRECIST\n* Incidence of hepatic decompensation within 30 days after treatment (defined as: bilirubin \\> 3 mg\u002FdL, new or worsened ascites, or hepatic encephalopathy)\n* Duration of response (DOR)\n\nExploratory Endpoints:\n\n* Depth of response (DpR)\n* Immune profile changes from baseline (assessed by multiparametric flow cytometry and single-cell RNA sequencing)",[61],{"label":62,"type":63,"description":64,"interventionNames":65},"Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC","EXPERIMENTAL","Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight \\\u003C 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.\n\nPartial TACE:\n\nPerformed within 4 weeks after starting lenvatinib.",[66,67],"Drug: Lenvatinib","Procedure: Partial transarterial chemoembolization (TACE)",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":55},"DRUG","Lenvatinib","Oral lenvatinib 12 mg once daily for body weight 60 kg or greater, or 8 mg once daily for body weight less than 60 kg. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.",[62],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"PROCEDURE","Partial transarterial chemoembolization (TACE)","Transarterial chemoembolization targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, performed within 4 weeks after starting lenvatinib. This liver-function-sparing approach limits the ischemic territory in order to preserve hepatic reserve.",[62],[80],"Partial TACE",[82],{"name":83,"role":84,"phone":85,"phoneExt":55,"email":86},"PO-Ting-Lin","CONTACT","886975362702","linpoting0101@gmail.com",{"type":88,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100656707","phase-2-pearl-trial-partial-tace-enhancing-anti-tumor-response-with-lenvatinib-in-unresectable-hcc-100656707",false,"NCT07827807","PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC","Pearl","Inclusion Criteria:\n\nDiagnosis of HCC confirmed by histology\u002Fcytology or typical imaging features, unsuitable for surgical resection or liver transplantation\n\n* Age ≥ 20 years at the time of signing informed consent\n* ECOG performance status 0-1\n* BCLC stage B or C (without main portal vein thrombosis)\n* Child-Pugh score 5-7 (Class A or B7) within 28 days of registration\n* Adequate bone marrow, liver, and renal function\n* Blood pressure adequately controlled\n* Ability to understand and sign written informed consent\n\nExclusion Criteria:\n\nPrior systemic therapy for HCC\n\n* Main portal vein thrombosis\n* Prior locoregional therapy within 4 weeks\n* Uncontrolled hypertension\n* Clinically significant cardiovascular disease within 6 months\n* Pregnancy or breastfeeding","ALL","20 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This is a single-arm, open-label, phase II clinical trial. Patients with unresectable hepatocellular carcinoma (HCC) who are eligible for lenvatinib treatment will receive partial transarterial chemoembolization (TACE) targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, in combination with standard lenvatinib therapy. The partial TACE approach is designed as a liver-function-sparing technique that limits ischemic territory while preserving hepatic reserve.",[106],"Hepatocellular Carcinoma",[108,109,110,111],"HCC","Liver tumor","TACE","lenvatinib","NOT_YET_RECRUITING","2026-09-14",{"date":115,"type":116},"2026-09-18","ACTUAL",{"date":118,"type":100},"2026-09-30",{"date":120,"type":100},"2029-05-31",{"name":5,"class":6}]