Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes
HCC - Hepatocellular Carcinoma · Diabetes
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 32 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Epalrestat plus HAIC, donafenib and tislelizumab
Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
Drug: Epalrestat · Drug: Donafenib + Tislelizumab · Procedure: HAIC
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary 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.
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 measures
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
Harbin Medical University Cancer HospitalHarbin, Heilongjiang, ChinaNot yet recruiting
Yanbian University HospitalYanji, Jilin, ChinaRecruiting
The First Hospital of China Medical UniversityShenyang, Liaoning, ChinaActive, not recruiting
Liaoning Cancer HospitalShenyang, Liaoning, ChinaNot yet recruiting
Study team and timeline
- Lead sponsor
- Haibo Shao
- Study start
- Jan 21, 2026 Actual
- Primary completion
- 2029-12 Estimated
- Study completion
- 2030-12 Estimated
- First posted
- Apr 30, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026