[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562953":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"dTACE-HAIC plus Bevacizumab and Atezolizumab","EXPERIMENTAL","dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres was used (100-300um, 300-500um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 200 mg intravenously every 2 weeks.",[13],"Procedure: dTACE-HAIC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","dTACE-HAIC","dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres were used (100-300um). 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. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Feng Duan, MD","Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Qunfang Zhou, MD","CONTACT","86 19868000115","zhouqun988509@163.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Ye Liang, MD","8618824105018","2575179115@qq.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Chinese PLA General hospital","RECRUITING","Beijing","None Selected","100853","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52,53],{"name":28,"role":29,"phone":20,"phoneExt":20,"email":31},{"name":23,"role":29,"phone":54,"phoneExt":20,"email":55},"8613910984586","duanfeng@vip.sina.com",{"type":25,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Zhou Qunfang","Clinical Professor","100562953","dtace-haic-combined-with-bevacizumab-and-atezolizumab-for-huge-hepatocellular-carcinoma-100562953",false,"NCT06609863","dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma","dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study","Inclusion Criteria:\n\n1. Clinical diagnosis of HCC.\n2. Age between 18 and 75 years;\n3. The maximum tumor size ≥10 cm;\n4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III\n5. limited metastases (≤5).\n6. Child-Pugh class A or B;\n7. Eastern Cooperative Group performance status (ECOG) score of 0-1;\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. Diffuse HCC;\n2. Extrahepatic metastasis \\>5;\n3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.\n7. Eastern Cooperative Group performance status (ECOG) score of ≥2;\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":70,"type":71},27,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.",[77,78,79,80],"Advanced Hepatocellular Carcinoma","Atezolizumab","Bevacizumab","Chemotherapy",[82,78,79],"hepatocellular carcinoma","2024-12-01",{"date":85,"type":86},"2024-12-03","ACTUAL",{"date":88,"type":86},"2024-10-01",{"date":90,"type":71},"2026-06-30",{"name":5,"class":6},1]