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Not yet recruiting NCT07557914

Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes

Phase II Interventional HCC - Hepatocellular Carcinoma Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epalrestat, Donafenib + Tislelizumab, HAIC.
Who it may be relevant to
Registry conditions: HCC - Hepatocellular Carcinoma, Diabetes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Drug Donafenib + Tislelizumab
    donafenib 0.2g BID, tislelizumab 200mg/21days
  • Procedure HAIC
    Include FOLFOX and RALOX.

Primary outcome measures

  • 12-month Event-free survival (EFS) Rate [Time frame: 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.]
Secondary outcome measures (11)
  • Event-free survival (EFS) [Time frame: 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.]
  • Overall survival (OS) [Time frame: Up to approximately 2 years]
  • Progression free survival(PFS) (Overall) [Time frame: From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.]
  • Progression free survival(PFS) of intra-hepatic lesions [Time frame: From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.]
  • Progression free survival(PFS) of extra-hepatic lesions [Time frame: From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.]
  • Objective response rate(ORR) per RESCIST 1.1 [Time frame: Up to approximately 2 years]
  • ORR per mRECIST [Time frame: Up to approximately 2 years]
  • PVTT response rate per mRECIST [Time frame: Up to approximately 2 years]
  • Disease control rate(DCR) per RESCIST 1.1 [Time frame: Up to approximately 2 years]
  • DCR per mRECIST [Time frame: Up to approximately 2 years]
  • Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Time frame: Up to approximately 2 years]

Eligibility criteria

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;
  • Pregnant and lactating women;
  • Known history of other malignancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT07557914 · kelunshen【2025】2025-861-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗