[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600575":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":43,"collaborators":18,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":18,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":27,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib","EXPERIMENTAL",[12],"Drug: lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","lparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg\u002Fkg, q3w; Lenvatinib: 8 mg once daily for patients weighing \\\u003C60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing； TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration.",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Tongguo Si, Doctor","CONTACT","+86 18526812877","18526812877@163.com",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Tianjin","Tianjin Municipality","300000","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.17667,39.14222,{"lat":37,"lon":36},[40],{"name":41,"role":22,"phone":42,"phoneExt":18,"email":24},"Tongguo Si","18526812877",{"type":44,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100600575","phase-2-lparomlimab-and-tuvonralimab-injection-in-combination-with-tace-and-lenvatinib-in-the-treatment-of-second-line-therapy-for-unresectable-intermediate-to-advanced-hepatocellular-carcinoma-100600575",false,"NCT07099274","Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma","A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Comprehension and voluntary signing of the study's informed consent form;\n* Age ≥18 years, any gender;\n* Histologically or clinically confirmed hepatocellular carcinoma;\n* Documented failure or intolerance to first-line therapy with PD-1\u002FPD-L1 inhibitor plus bevacizumab;\n* ECOG performance status 0-2;\n* Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;\n* Life expectancy ≥3 months;\n* At least one measurable target lesion confirmed by screening imaging per RECIST v1.1;\n* Adequate organ and bone marrow function within 7 days prior to initial study treatment;\n* Active HBV\u002FHCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose.\n\n  2.Exclusion Criteria:\n* Inability to comply with the study protocol or procedures;\n* Histologically\u002Fcytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;\n* History of liver transplantation or planned transplantation;\n* Presence of central nervous system metastases and\u002For leptomeningeal carcinomatosis;\n* Baseline imaging showing Vp4 portal vein tumor thrombosis;\n* Hypersensitivity to any study drug components or history of severe allergic reactions;\n* Concurrent HBV and HCV co-infection;\n* Clinically significant ascites requiring intervention during screening;\n* Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;\n* Esophageal\u002Fgastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;\n* Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis\u002Forganizing pneumonia affecting immune-related pulmonary toxicity assessment;\n* Uncontrolled hypertension (SBP≥160 mmHg and\u002For DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);\n* Uncontrolled clinically significant infections requiring IV antimicrobial therapy;\n* Proteinuria ≥2+ (≥1.0g\u002F24h);\n* History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;\n* Arterial\u002Fvenous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);\n* Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;\n* Unhealed fractures or chronic non-healing wounds;\n* Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;\n* Other malignancies within 5 years except curatively resected basal\u002Fsquamous cell skin carcinoma or cervical carcinoma in situ;\n* Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;\n* Prior allogeneic bone marrow or solid organ transplantation;\n* Investigator assessment of ineligibility based on medical\u002Fsafety reasons.","ALL","18 Years",{"count":55,"type":56},29,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1\u002F CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.",[62],"HCC",[64,65,66],"Iparomlimab and Tuvonralimab Injection","TACE","Lenvatinib","2025-08-22",{"date":69,"type":70},"2025-08-29","ACTUAL",{"date":67,"type":70},{"date":73,"type":56},"2029-12-30",{"name":5,"class":6},1]