Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

Patients diagnosed with hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage B (with large tumor burden exceeding the up-to-seven criteria) or stage C, as determined by consensus of a multidisciplinary hepatobiliary surgical team, corresponding to TNM stages II-IV with preserved liver function (intermediate to advanced HCC), who are deemed unresectable.

No prior systemic therapy for HCC.

First-line treatment regimen must include an immune checkpoint inhibitor with/without interventional therapy .

White blood cell count ≥ 4.0 × 10⁹/L

Disqualifiers

Concomitant severe impairment of vital organ function (including cardiac, pulmonary, renal, or other major organ systems), active infections other than viral hepatitis, or other severe comorbid conditions that would render the patient unable to tolerate treatment.

Prior treatment with any sodium-glucose cotransporter 2 (SGLT2) inhibitor, including but not limited to canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, luseogliflozin, and tofogliflozin.

Presence of contraindications to any component of the combination therapy, including immune checkpoint inhibitors, targeted therapy, or interventional therapy.

History of other active malignancies.

Trial design

Treatments tested in this trial

  • Dapagliflozin
  • Donafenib
  • Tislelizumab

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators