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NOT YET RECRUITING
NCT07557914
PHASE2

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

Sponsor: Haibo Shao

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-10

Completion Date

2029-02

Last Updated

2026-09-21

Healthy Volunteers

No

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.

Locations (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China