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

ConditionsHCC - Hepatocellular CarcinomaDiabetes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaibo Shao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

    Include FOLFOX and RALOX.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Epalrestat plus HAIC, donafenib and tislelizumabExperimental treatment 3 interventions

Trial outcomes

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.)

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 outcomes

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).

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.
2

Overall survival (OS)

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

Time frame
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.

Time frame
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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haibo Shao

Lead sponsor

First Hospital of China Medical University

Sponsor institution

First Hospital of China Medical University

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

The General Hospital of Northern Theater Command

Collaborator

The Affiliated Hospital of Yanbian University

Collaborator

Harbin Medical University Third Affiliated Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: