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NCT Number: NCT07557914

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

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Liver Diseases Liver Neoplasms Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epalrestat

Drug

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.

Donafenib + Tislelizumab

Drug

donafenib 0.2g BID, tislelizumab 200mg/21days

HAIC

Procedure

Include FOLFOX and RALOX.

Other names: hepatic artery infusion chemotherapy

Primary outcomes

  1. 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.

    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

  1. 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.

    Defined as the time from treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs).

  2. Overall survival (OS)

    Time frame: Up to approximately 2 years

    The OS is defined as the time from the enrollment to death due to any cause.

  3. 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.

    The PFS is defined as the time from the enrollment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.

  4. 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.

    The PFS is defined as the time from the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.

  5. 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.

    The PFS is defined as the time from the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.

  6. Objective response rate(ORR) per RESCIST 1.1

    Time frame: Up to approximately 2 years

    The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.

  7. ORR per mRECIST

    Time frame: Up to approximately 2 years

    The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.

  8. PVTT response rate per mRECIST

    Time frame: Up to approximately 2 years

    The PVTT response rate is defined as the proportion of patients with a documented CR or PR of PVTT.

    According to the Vp classification:

    CR: PVTT disappears or the portal vein becomes completely unobstructed. PR: Decrease in VP classification. SD: Without PR and PD. PD: Increase in VP classification.

  9. Disease control rate(DCR) per RESCIST 1.1

    Time frame: Up to approximately 2 years

    The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per RECIST 1.1.

  10. DCR per mRECIST

    Time frame: Up to approximately 2 years

    The DCR is defined as the proportion of patients with a documented complete response(CR), partial response(PR) or stable disease(SD) per mRECIST.

  11. Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0

    Time frame: Up to approximately 2 years

    The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongbin Zou

CONTACT

[email protected]

+8618040026871

Sponsors and collaborators

Lead sponsor

Haibo Shao

Other

Collaborators

  • First Hospital of China Medical University
  • Harbin Medical University Third Affiliated Hospital
  • Liaoning Cancer Hospital & Institute
  • The Affiliated Hospital of Yanbian University
  • The General Hospital of Northern Theater Command

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 30, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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