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Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes - A Multicenter, Prospective, Single-arm Clinical Study

NCT07557914 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • HCC - Hepatocellular Carcinoma
  • Diabetes

Interventions

DRUG

Epalrestat

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.

DRUG

Donafenib + Tislelizumab

donafenib 0.2g BID, tislelizumab 200mg/21days

PROCEDURE

HAIC

Include FOLFOX and RALOX.

Sponsors & Collaborators

  • First Hospital of China Medical University

    collaborator OTHER

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • The General Hospital of Northern Theater Command

    collaborator OTHER

  • The Affiliated Hospital of Yanbian University

    collaborator OTHER

  • Harbin Medical University Third Affiliated Hospital

    collaborator OTHER

  • Haibo Shao

    lead OTHER

Principal Investigators

  • Haibo Shao · First Hospital of China Medical University

  • Tao Han · First Hospital of China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07557914 on ClinicalTrials.gov