NCT07557914

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
34mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Feb 2029

Study Start

First participant enrolled

April 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

April 22, 2026

Last Update Submit

April 22, 2026

Conditions

HCC - Hepatocellular CarcinomaDiabetes

Keywords

hepatic arterial infusion chemotherapyDonafenibTislelizumabHCC - Hepatocellular CarcinomaDiabetes

Outcome Measures

Primary Outcomes (1)

  • 12-month Event-free survival (EFS) Rate

    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.)

    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 Outcomes (11)

  • Event-free survival (EFS)

    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)

    Up to approximately 2 years

  • Progression free survival(PFS) (Overall)

    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

    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

    From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.

  • +6 more secondary outcomes

Study Arms (1)

Epalrestat plus HAIC, donafenib and tislelizumab

EXPERIMENTAL

Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days

Drug: EpalrestatDrug: Donafenib + TislelizumabProcedure: HAIC

Interventions

EpalrestatDRUG

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.

Epalrestat plus HAIC, donafenib and tislelizumab
Donafenib + TislelizumabDRUG

donafenib 0.2g BID, tislelizumab 200mg/21days

Epalrestat plus HAIC, donafenib and tislelizumab
HAICPROCEDURE

Include FOLFOX and RALOX.

Also known as: hepatic artery infusion chemotherapy
Epalrestat plus HAIC, donafenib and tislelizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularDiabetes Mellitus

Interventions

epalrestatdonafenibtislelizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Haibo Shao

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

  • Tao Han

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbin Zou

CONTACT

+8618040026871hongbinzou300@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

CN(1)