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

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.

Inclusion Criteria:

1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;

Exclusion Criteria:

1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
4. Renal failure: Creatinine clearance rate < 30 mL/min;
5. Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA > 2000 IU/mL);
7. ECOG PS ≥ 2 or extremely poor overall condition;
8. Diabetic patients with acute ketoacidosis or during the period of severe infection;
9. Pregnant and lactating women;
10. Known history of other malignancy.