Not Yet RecruitingPhase 2

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

China32 participantsStarted 2026-04

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

12-month Event-free survival (EFS) Rate

Timeframe: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.

Trial details

NCT IDNCT07557914

SponsorHaibo Shao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Hongbin Zou

+8618040026871 hongbinzou300@gmail.com

View on ClinicalTrials.gov More HCC - Hepatocellular Carcinoma trials