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HCC - Hepatocellular CarcinomaPhase 2NCT07557914

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

A Phase 2 study testing Epalrestat, Donafenib + Tislelizumab and HAIC in people with HCC - Hepatocellular Carcinoma and Diabetes, run by Haibo Shao at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HCC - Hepatocellular Carcinoma, Diabetes
What is being tested?
Epalrestat, Donafenib + Tislelizumab and HAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
Oct 2026to Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongbin Zou contact

+8618040026871

hongbinzou300@gmail.com

China1 site

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Haibo Shao, +8613840150051, haiboshao@aliyun.com

    Tao Han, 8617790995045, than1984@sina.com

Other trials in China

About this study

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

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.

Being tested
Epalrestat, Donafenib + Tislelizumab, HAIC
Keywords
hepatic arterial infusion chemotherapy, Donafenib, Tislelizumab, HCC - Hepatocellular Carcinoma, Diabetes
Medical subject headings
Carcinoma, Hepatocellular, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Donafenib + TislelizumabDrug

    donafenib 0.2g BID, tislelizumab 200mg/21days

  • HAICProcedure or surgery

    Also called hepatic artery infusion chemotherapy

    Include FOLFOX and RALOX.

Study groups in NCT07557914
Study groupRoleWhat they receive
Epalrestat plus HAIC, donafenib and tislelizumabExperimentalEpalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
Receives: Drug: Epalrestat; Drug: Donafenib + Tislelizumab; Procedure: HAIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.)

    Measured: 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)

  1. Event-free survival (EFS)

    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).

    Measured: 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.

  2. Overall survival (OS)

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

    Measured: Up to approximately 2 years

  3. Progression free survival(PFS) (Overall)

    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.

    Measured: From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.

  4. Progression free survival(PFS) of intra-hepatic lesions

    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.

    Measured: From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.

  5. Progression free survival(PFS) of extra-hepatic lesions

    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.

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

  6. Objective response rate(ORR) per RESCIST 1.1

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

    Measured: Up to approximately 2 years

  7. ORR per mRECIST

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

    Measured: Up to approximately 2 years

  8. PVTT response rate per mRECIST

    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.

    Measured: Up to approximately 2 years

  9. Disease control rate(DCR) per RESCIST 1.1

    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.

    Measured: Up to approximately 2 years

  10. DCR per mRECIST

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

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07557914
Sponsor's protocol ID
kelunshen【2025】2025-861-2
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
21 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Consent and privacy: Participants usually only agreed to data use in the original study. Sharing IPD may violate that agreement. And we want to protect our academic credit and avoid misuse of the data.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epalrestat, Donafenib + Tislelizumab and HAIC in people with HCC - Hepatocellular Carcinoma and Diabetes, run by Haibo Shao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongbin Zou (+8618040026871, hongbinzou300@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07557914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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