[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653635":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":26,"armGroups":30,"interventions":39,"overallOfficials":26,"centralContacts":54,"locations":60,"responsibleParty":75,"collaborators":26,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-free survival (DFS)","Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first.","From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.",[14],{"measure":15,"description":16,"timeFrame":17},"Overall survival (OS)","Overall survival (OS) is defined as the time from randomization to death from any cause. For subjects lost to follow-up before death, the time of last follow-up is generally used as the death time.","From the date of randomization until death from any cause, assessed up to 28 months.",[19],{"measure":20,"description":21,"timeFrame":22},"Safety endpoints","Exposure to the investigational drug and the incidence, nature, and severity of adverse events (including serious adverse events) will be recorded.","Through study completion, an average of 28 months.",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":26},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"HAIC+Targeted Therapy +PD-1 Inhibitor","EXPERIMENTAL","Hepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows:\n\nOxaliplatin 65 mg\u002Fm², IA (intra-arterial), Day 1, 0-5 hours:\n\n5-FU 1200 mg\u002Fm², IA, maintained for 23 hours.\n\nAfter catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge.\n\nThe above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles.\n\nTargeted drugs:\n\nIncluding lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight \\\u003C60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects.\n\nPD-1 inhibitors\n\n: sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt.\n\nThis study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the",[36,37,38],"Radiation: HAIC","Drug: Donafenib + lenvatinib+apatinib","Drug: Sintilimab+camrelizumab+tislelizumab",[40,45,50],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":26},"RADIATION","HAIC","Oxaliplatin and 5-Fluorouracil（5-FU）administeredvia hepatic artery infusion",[32],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":26},"DRUG","Donafenib + lenvatinib+apatinib","Oraltargeted therapy administered daily",[32],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"Sintilimab+camrelizumab+tislelizumab","PD--1 inhibitor administered viaintravenous infusion",[32],[55],{"name":56,"role":57,"phone":58,"phoneExt":26,"email":59},"Wenlong Zhai, MD","CONTACT","+86-371-66862231","ven0371@126.com",[61],{"facility":5,"status":26,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Zhengzhou","Henan","450052","China","CN",{"type":68,"coordinates":69},"Point",[70,71],113.64861,34.75778,{"lat":71,"lon":70},[74],{"name":56,"role":57,"phone":58,"phoneExt":26,"email":59},{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Zhai Wenlong","Porfessor","100653635","phase-4-a-prospective-single-arm-open-label-clinical-study-of-the-efficacy-and-safety-of-hepatic-arterial-infusion-chemotherapy-combined-with-targeted-therapy-and-a-pd-1-inhibitor-in-patients-with-postoperative-hepatocellular-carcinoma-and-microvascular-invasion-100653635",false,"NCT07790419","A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion","Inclusion Criteria:\n\n1. Age 18-80 years, male or female;\n2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;\n3. Microvascular invasion (MVI) grade ≥ 1\n4. No other history of tumors and no preoperative anticancer treatment.\n5. ECOG: 0-1;\n6. Baseline blood count tests and blood biochemistry must meet the following criteria:\n\n   Hemoglobin ≥80 g\u002FL;\n\n   Absolute neutrophil count ≥1.5×109\u002FL;\n\n   Platelet count ≥50×109\u002FL;\n\n   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);\n\n   Total bilirubin ≤3 times ULN;\n\n   Serum creatinine ≤1.5 times ULN;\n\n   Albumin ≥28 g\u002FL; prothrombin time (PT) ≤19.5 s;\n\n   International normalized ratio (INR) ≤2.3\n7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;\n8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);\n\n  2\\. Pregnancy or lactation;\n\n  3\\. Over 80 years old;\n\n  4\\. Prior systemic chemotherapy or radiotherapy;\n\n  5\\. Concomitant malignant pleural effusion or ascites;\n\n  6\\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n\n  7\\. Concomitant infection requiring anti-infective treatment;\n\n  8\\. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;\n\n  9\\. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;\n\n  10\\. Uncorrectable coagulation disorders;\n\n  11\\. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;\n\n  12\\. History of myocardial infarction within 12 months, or cardiac function class III or IV;\n\n  13\\. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;\n\n  14\\. Individuals deemed unsuitable for inclusion by the investigator.","ALL","18 Years","80 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion",[96],"Liver Cancer",[42],"NOT_YET_RECRUITING","2026-08-24",{"date":101,"type":102},"2026-08-27","ACTUAL",{"date":104,"type":90},"2026-08-30",{"date":106,"type":90},"2028-12-31",{"name":77,"class":6},1]