hepatocellular carcinoma
Conditions
Interventions
Treatment group:Carvedilol Combined with Atorvastatin
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Pathologically and/or clinically confirmed unresectable hepatocellular carcinoma (HCC). 3. ECOG Performance Status (PS) score 0–1. 4. Child-Pugh class A or B. 5. Recovery from prior treatment-related toxicities to =Grade 1 (per NCI-CTCAE v5.0). 6. Liver cirrhosis confirmed by abdominal ultrasound or CT. 7. Voluntarily signed informed consent form (ICF). 8. >=1 measurable lesion assessed per mRECIST v1.1 criteria.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the study drugs. 2. Pregnant or lactating women, or patients planning pregnancy during the study period. 3. Patients with urinary flow obstruction. 4. Renal dysfunction (eGFR 1.5×ULN). 5. Patients unable to take oral medications. 6. Autoimmune diseases or use of immunosuppressive therapy within the past 6 months. 7. Active liver disease (e.g., acute hepatitis, uncontrolled HBV/HCV). 8. Acute liver failure or decompensated cirrhosis (Child-Pugh C). 9. Active infections requiring systemic treatment (e.g., pneumonia, sepsis). 10. HIV-positive or other immunocompromised conditions. 11. Other active malignancies requiring treatment (except cured non-melanoma skin cancer or carcinoma in situ). 12. Unresolved adverse reactions from prior medications (Grade >=2 per CTCAE v5.0). 13. Psychiatric disorders or substance abuse affecting compliance. 14. Other confounding factors (investigator’s discretion). 15. Concurrent use of immunomodulatory drugs (e.g., systemic corticosteroids >10 mg/day prednisone equivalent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic vein pressure gradient, HVPG;Tumor response;quality of life;liver function;progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactBo Liu
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed