[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521518":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":22,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":22,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":22,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":22,"overallStatus":51,"whyStopped":22,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"bTAE-HAIC combined with Lenvatinib and Sintilimab","EXPERIMENTAL","bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Sintilimab, 200 mg intravenously every 3 weeks.",[13,14,15],"Procedure: bTAE-HAIC","Drug: Lenvatinib","Drug: Sintilimab",[17,23,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","bTAE-HAIC","bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper\u002Fleft\u002Fright hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg\u002Fm2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg\u002Fm2 leucovorin from hour 2 to 4 on day 1, and 400 mg\u002Fm2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg\u002Fm2 fluorouracil over 46 h on days 1 and 2.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Lenvatinib","12 mg (or 8 mg) once daily (QD) oral dosing.",[9],[29],"TKI inhibits",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Sintilimab","200mg intravenously every 32 weeks",[9],[35],"programmed cell death protein-1 (PD-1) antibody",[37,40],{"name":38,"affiliation":5,"role":39},"Zhimei Hunag, MD","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":39},"Jinhua Huang, Professor",[43],{"name":44,"role":45,"phone":46,"phoneExt":22,"email":47},"Qunfnag Zhou, MD","CONTACT","86 19868000115","zhouqun988509@163.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":58,"coordinates":59},"Point",[60,61],113.25,23.11667,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":46,"phoneExt":22,"email":47},"Qunfang Zhou, MD",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Zhou Qunfang","Clinical Professor","100521518","btae-haic-combined-with-lenvatinib-and-sintilimab-for-infiltrative-hepatocellular-carcinoma-100521518",false,"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.","ALL","18 Years","75 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.",[88,89,90,25,31],"Liver Diseases","Hepatocellular Carcinoma","Immunotherapy","2024-08-08",{"date":93,"type":94},"2024-08-09","ACTUAL",{"date":96,"type":94},"2024-05-20",{"date":98,"type":82},"2025-06-30",{"name":5,"class":6},1]