Hepatocellular Carcinoma (HCC)Phase 2NCT07729592
Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome
A Phase 2 study testing Dapagliflozin, Donafenib and Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Dapagliflozin, Donafenib and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
- Diagnosis of metabolic syndrome according to the National Cholesterol Education Programme-Adult Treatment Panel III (NCEP-ATP III) criteria, requiring at least 3 of the following 5 criteria:
- Central obesity (waist circumference): ≥ 90 cm in males, ≥ 80 cm in females; (2) Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or receiving specific treatment for this lipid abnormality; (3) Reduced high-density lipoprotein cholesterol (HDL-C): < 40 mg/dL (1.0 mmol/L) in males, < 50 mg/dL (1.3 mmol/L) in females, or receiving specific treatment for this lipid abnormality; (4) Elevated blood pressure: systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or previously diagnosed hypertension and receiving antihypertensive treatment; (5) Elevated fasting glucose: ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes mellitus.
- 5. Age between 18 and 75 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy > 3 months. 8. At least one measurable lesion according to RECIST version 1.1 (i.e., longest diameter ≥ 10 mm on contrast-enhanced spiral CT or contrast-enhanced MRI, or short-axis diameter ≥ 15 mm for enlarged lymph nodes; lesions previously treated with local therapy may be considered target lesions only if disease progression has been clearly documented per RECIST v1.1).
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- 9. Adequate organ function, meeting the following laboratory criteria:
- White blood cell count ≥ 4.0 × 10⁹/L
- Neutrophil count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 80.0 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- Serum albumin ≥ 2.8 g/dL
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- ALT/AST/ALKP ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min
- No concomitant severe organic disease. 10. Ability to understand and willingness to provide written informed consent prior to any study-specific procedures, and agreement to comply with the study medication administration and post-treatment follow-up schedule as per protocol.
Who cannot join
- 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.
- Concurrent autoimmune diseases, or other conditions requiring long-term systemic corticosteroid therapy.
- Known or suspected hypersensitivity to the study drug or to any agent administered in association with this trial.
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- History of organ transplantation.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, may interfere with patient enrollment or evaluation of study outcomes.
- Refusal to comply with the follow-up requirements as specified in the protocol, or refusal to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
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)
- Being tested
- Dapagliflozin, Donafenib, Tislelizumab
- Keywords
- HCC, dapagliflozin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin, 10mg, once a day, orally
DonafenibDrug
Donafenib, 400mg，once a day, orally
TislelizumabDrug
Tislelizumab, 200mg, every 3 weeks, intravenously
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | first-line treatment for unresectable HCC Receives: Drug: Donafenib; Drug: Tislelizumab |
| Combination group | Experimental | dapagliflozin (10mg, once a day, orally) added to first-line treatment for unresectable HCC Receives: Drug: Dapagliflozin; Drug: Donafenib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Measured: Three years
Secondary outcomes (3)
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Measured: Three years
Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression (defined by mRECIST 1.1) or death of any cause.
Measured: Three years
Adverse events (AE)
Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Min-Shan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729592
- Sponsor's protocol ID
- B2026-402-01
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are available from the corresponding author (Minshan Chen and Yaojun Zhang) by request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07729592
- Acronym / sponsor ID
- B2026-402-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Donafenib, Drug: Tislelizumabfirst-line treatment for unresectable HCC |
| Combination group | Experimental | Drug: Dapagliflozin, Drug: Donafenib, Drug: Tislelizumabdapagliflozin (10mg, once a day, orally) added to first-line treatment for unresectable HCC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 .
- Diagnosis of metabolic syndrome according to the National Cholesterol Education Programme-Adult Treatment Panel III (NCEP-ATP III) criteria, requiring at least 3 of the following 5 criteria:
- Central obesity (waist circumference): ≥ 90 cm in males, ≥ 80 cm in females; (2) Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or receiving specific treatment for this lipid abnormality; (3) Reduced high-density lipoprotein cholesterol (HDL-C): < 40 mg/dL (1.0 mmol/L) in males, < 50 mg/dL (1.3 mmol/L) in females, or receiving specific treatment for this lipid abnormality; (4) Elevated blood pressure: systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or previously diagnosed hypertension and receiving antihypertensive treatment; (5) Elevated fasting glucose: ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes mellitus.
Key exclusion criteria (10 listed)
- 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.
- Concurrent autoimmune diseases, or other conditions requiring long-term systemic corticosteroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin, 10mg, once a day, orally | Drug | Combination group |
| DonafenibDonafenib, 400mg，once a day, orally | Drug | Combination group, Control group |
| TislelizumabTislelizumab, 200mg, every 3 weeks, intravenously | Drug | Combination group, Control group |
Primary outcome
Objective Response Rate (ORR)
Time frame: Three years
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
3 secondary outcomes
Overall Survival (OS)
Time frame: Three years
Progression-free Survival (PFS)
Time frame: Three years
Adverse events (AE)
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD are available from the corresponding author (Minshan Chen and Yaojun Zhang) by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin, Donafenib and Tislelizumab in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minshan Chen (+86 13902241061, chenmsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.