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

Sponsor
Haibo Shao
Study ID
NCT07557914
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • HCC - Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 30, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

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. ]

Central Contacts

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