NCT07557914Not 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 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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- Oct 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Haibo Shao
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07557914
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- From Oct 2026 to the primary completion date, Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
- Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
- 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;
- Known history of other malignancy.
Lab values
- Renal failure: Creatinine clearance rate \< 30 mL/min;
- Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
Other
- Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
- Pregnant and lactating women;
Who the study is looking for
- 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;
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.