[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635840":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":40,"locations":46,"responsibleParty":67,"collaborators":70,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":22,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":22,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":22,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"First Hospital of China Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Epalrestat plus HAIC, donafenib and tislelizumab","EXPERIMENTAL","Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days",[13,14,15],"Drug: Epalrestat","Drug: Donafenib + Tislelizumab","Procedure: HAIC",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Epalrestat","For the first 6 patients in the safety lead-in period, the starting dose of epalrestat was 50 mg, three times per day. If dose-limiting toxicity (DLT) occurred in the first 6 patients, the dose for the second round of 6 patients in the safety lead-in period would be adjusted to 50 mg, twice per day. If DLT occurred in the second round of 6 patients, the dose for the third round of 6 patients in the safety lead-in period would be adjusted to 50 mg, once per day.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Donafenib + Tislelizumab","donafenib 0.2g BID, tislelizumab 200mg\u002F21days",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","HAIC","Include FOLFOX and RALOX.",[9],[33],"hepatic artery infusion chemotherapy",[35,38],{"name":36,"affiliation":5,"role":37},"Haibo Shao","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Tao Han",[41],{"name":42,"role":43,"phone":44,"phoneExt":22,"email":45},"Hongbin Zou","CONTACT","+8618040026871","hongbinzou300@gmail.com",[47],{"facility":48,"status":22,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"The First Hospital of China Medical University","Shenyang","Liaoning","110000","China","CN",{"type":55,"coordinates":56},"Point",[57,58],123.43278,41.79222,{"lat":58,"lon":57},[61,64],{"name":36,"role":43,"phone":62,"phoneExt":22,"email":63},"+8613840150051","haiboshao@aliyun.com",{"name":39,"role":43,"phone":65,"phoneExt":22,"email":66},"8617790995045","than1984@sina.com",{"type":68,"investigatorFullName":36,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Professor, MD, PhD",[71,72,74,76,78],{"name":5,"class":6},{"name":73,"class":6},"Liaoning Cancer Hospital & Institute",{"name":75,"class":6},"The General Hospital of Northern Theater Command",{"name":77,"class":6},"The Affiliated Hospital of Yanbian University",{"name":79,"class":6},"Harbin Medical University Third Affiliated Hospital","100635840","phase-2-epalrestat-combined-with-haic-donafenib-and-tislelizumab-as-first-line-treatment-for-patients-with-unresectable-hcc-and-diabetes-100635840",false,"NCT07557914","Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes","A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes","Inclusion Criteria:\n\n1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);\n2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;\n3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;\n4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;\n\nExclusion Criteria:\n\n1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;\n2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);\n3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;\n4. Renal failure: Creatinine clearance rate \\\u003C 30 mL\u002Fmin;\n5. Thrombocytopenia (less than 50×10⁹\u002FL) or coagulation dysfunction (INR greater than 1.5);\n6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \\> 2000 IU\u002FmL);\n7. ECOG PS ≥ 2 or extremely poor overall condition;\n8. Diabetic patients with acute ketoacidosis or during the period of severe infection;\n9. Pregnant and lactating women;\n10. Known history of other malignancy.","ALL","18 Years","80 Years",{"count":91,"type":92},32,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.",[98,99],"HCC - Hepatocellular Carcinoma","Diabetes",[101,102,103,98,99],"hepatic arterial infusion chemotherapy","Donafenib","Tislelizumab","NOT_YET_RECRUITING","2026-06-01",{"date":107,"type":108},"2026-06-03","ACTUAL",{"date":110,"type":92},"2026-06",{"date":112,"type":92},"2029-02",{"name":36,"class":6},1]