Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
| HCC - Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib + Tislelizumab | Drug | — | UNRESOLVED |
| Epalrestat | Drug | — | UNRESOLVED |
| HAIC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epalrestat plus HAIC, donafenib and tislelizumab
- description
- Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
- interventionNames
- Drug: Epalrestat
- Drug: Donafenib + Tislelizumab
- Procedure: HAIC
Primary outcomes (1)
- measure
- 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.
- description
- The proportion of patients who have remained event-free from the start of treatment until the 12-month time point.(Predefined events include: progression of disease, death for any reason, terminate the treatment due to intolerable AEs.)
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available