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NOT YET RECRUITING
NCT07729592
PHASE2

Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this interventional study (clinical trial) is to evaluate the efficacy and safety of adding dapagliflozin to first-line standard therapy in patients with unresectable hepatocellular carcinoma (HCC) and comorbid metabolic syndrome. The main questions it aims to answer are: Does the addition of dapagliflozin to first-line therapy improve the objective response rate (ORR) compared with first-line therapy alone in this patient population? What are the differences between the two treatment groups in terms of overall survival (OS), progression-free survival (PFS), and safety/tolerability profiles? Researchers will compare the combination group (dapagliflozin plus first-line standard therapy) with the control group (first-line standard therapy alone) to determine whether the addition of dapagliflozin provides superior clinical benefit. Participants in the combination group will receive dapagliflozin in addition to their prescribed first-line standard therapy, while participants in the control group will receive first-line standard therapy alone. All participants will be regularly monitored for tumor response, survival outcomes, and adverse events throughout the study period. The findings of this trial are expected to provide clinical evidence supporting the use of dapagliflozin as an adjunctive therapy in patients with advanced unresectable HCC and metabolic syndrome, potentially enhancing the tumor response rate to existing standard-of-care treatments.

Official title: A Single-Center, Phase II, Randomized Controlled Clinical Study to Evaluate Dapagliflozin as an Addition to First-Line Treatment for Unresectable Hepatocellular Carcinoma With Metabolic Syndrome

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-07

Completion Date

2029-07

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin

Dapagliflozin, 10mg, once a day, orally

DRUG

Donafenib

Donafenib, 400mg,once a day, orally

DRUG

Tislelizumab

Tislelizumab, 200mg, every 3 weeks, intravenously