[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634142":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":25,"slug":20,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":20,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":20,"enrollmentInfo":32,"targetDuration":20,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":44,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Firsekibart Combined with Tislelizumab and Lenvatinib in Advanced TP53-Mutated Unresectable HCC","EXPERIMENTAL","articipants will receive Firsekibart 200 mg IV on Day 1 every 3 weeks, followed 1 hour later by Tislelizumab 200 mg IV on Day 1 every 3 weeks, and Lenvatinib orally once daily at 8 mg for patients ≤60 kg or 12 mg for patients \\>60 kg. Treatment continues until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or other protocol-specified discontinuation criteria.",[13],"Drug: Firsekibart + Tislelizumab + Lenvatinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Firsekibart + Tislelizumab + Lenvatinib","Participants will receive Firsekibart 200 mg IV on Day 1 every 3 weeks, followed 1 hour later by Tislelizumab 200 mg IV on Day 1 every 3 weeks, and Lenvatinib orally once daily (8 mg for ≤60 kg or 12 mg for \\>60 kg). Treatment continues until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or other protocol-specified discontinuation criteria.",[9],null,{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Zhang Bi Xiang, MD","Professor","100634142",false,"NCT07535840","A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Ability to understand and sign written informed consent prior to any study-related procedures.\n\nAge ≥18 years at the time of signing informed consent.\n\nHistologically or cytologically confirmed advanced or unresectable hepatocellular carcinoma (HCC).\n\nDocumented disease progression after prior systemic immunotherapy, including at least one PD-(L)1 inhibitor.\n\nConfirmed TP53 mutation in fresh liver tumor tissue by central laboratory testing.\n\nDetermined by liver tumor MDT to be unsuitable for curative surgery (R0 resection not feasible, insufficient normal liver volume, or other criteria).\n\nBCLC stage B or C.\n\nAt least one measurable lesion per RECIST v1.1 confirmed by BICR.\n\nECOG performance status 0-1.\n\nChild-Pugh class A within 7 days prior to randomization.\n\nAdequate organ and bone marrow function within 7 days prior to enrollment:\n\nANC ≥1.5×10\\^9\u002FL, Platelets ≥75×10\\^9\u002FL, HGB ≥9 g\u002FdL\n\nTBIL ≤2×ULN, ALT\u002FAST ≤5×ULN, Albumin ≥28 g\u002FL, ALP ≤5×ULN\n\nCreatinine ≤1.5×ULN or CCr ≥50 mL\u002Fmin, urine protein \\\u003C2+ (or 24-h urine protein \\\u003C1 g if baseline ≥2+)\n\nINR ≤2.3 or PT prolongation ≤6 sec\n\nExpected survival ≥12 weeks.\n\nWomen of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 6 months after last dose.\n\nAbility and willingness to comply with study procedures and visits.\n\nExclusion Criteria:\n\n* Candidates suitable for local curative therapy.\n\nMixed liver tumors containing sarcomatoid or intrahepatic cholangiocarcinoma components.\n\nHematologic malignancies.\n\nHistory of hepatic encephalopathy or prior liver transplantation.\n\nSymptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; asymptomatic small effusions allowed.\n\nActive HBV (HBV DNA \\>2000 IU\u002FmL) or HCV (HCV RNA \\>10\\^3 copies\u002FmL) infection; co-infection HBsAg+\u002FHCV Ab+ excluded.\n\nCNS metastases.\n\nSignificant recent variceal bleeding (within 6 months).\n\nLife-threatening hemorrhagic events within 3 months.\n\nSignificant thromboembolic events within 6 months.\n\nUse of high-dose aspirin (\\>325 mg\u002Fday) or other platelet inhibitors within 2 weeks prior to first dose.\n\nUnresolved grade ≥2 toxicities from prior therapies (excluding hair loss or asymptomatic lab abnormalities).\n\nSymptomatic heart failure NYHA II-IV or LVEF \\\u003C50%.\n\nUncontrolled arrhythmias or congenital long QT syndrome, QTc \\>500 ms.\n\nActive bleeding disorders or on thrombolytic therapy.\n\nRecent history of gastrointestinal perforation, fistula, obstruction, or significant bowel disease.\n\nRadiotherapy within 3-7 weeks prior to first dose with residual toxicity.\n\nHistory of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced lung injury, or severe impaired lung function.\n\nActive tuberculosis or treatment for TB within 1 year.\n\nHIV infection or active, untreated syphilis.\n\nActive or uncontrolled severe infection within 4 weeks prior to first dose.\n\nActive autoimmune disease requiring systemic treatment within 2 years. Known primary immunodeficiency.\n\nUse of systemic immunosuppressants within 4 weeks prior to first dose (nasal\u002Finhaled steroids at physiologic dose allowed).\n\nReceipt of live attenuated vaccines within 4 weeks prior to first dose.\n\nMajor surgery within 4 weeks prior to first dose, or unhealed wounds. Minor procedures like IV lines excluded.\n\nUncontrolled metabolic disorders or organ\u002Fsystemic disease posing excess risk.\n\nHistory of other malignancy within 5 years, except curatively treated basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma.\n\nKnown hypersensitivity to study drugs or formulation components.\n\nHistory of aortic dissection or visceral artery aneurysm.\n\nParticipation in another clinical trial within 4 weeks prior to first dose.\n\nPregnant or breastfeeding women.\n\nExtensive metastatic disease (≥5 lesions) or major vascular invasion.\n\nOther acute or chronic diseases, psychiatric conditions, or lab abnormalities deemed by investigator to increase risk or interfere with study.","ALL","18 Years",{"count":33,"type":34},25,"ESTIMATED","INTERVENTIONAL",[37],"NA","This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.\n\nEligible patients will receive:\n\nFuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.\n\nSafety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.\n\nPrimary Objective: To assess the objective response rate (ORR) of the combination therapy.\n\nSecondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.",[40,41,42,43],"HCC - Hepatocellular Carcinoma","TP53 Gene Mutation","Unresectable","Resistant Cancer",[45,46,47,48,49,50,51],"Firsekibart","Tislelizumab","Lenvatinib","TP53-mutant hepatocellular carcinoma","Unresectable HCC","Advanced liver cancer","Single-arm study","NOT_YET_RECRUITING","2026-04-10",{"date":55,"type":56},"2026-04-17","ACTUAL",{"date":58,"type":34},"2026-05",{"date":60,"type":34},"2027-06",{"name":5,"class":6}]