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Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome

NCT07729592 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-07-31
Completion
2029-07-31

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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 NCT07729592 on ClinicalTrials.gov