Hepatocellular Carcinoma with Narrow Margins
Conditions
Interventions
Experimental group:Adjuvant therapy with tislelizumab combined with stereotactic body radiation therapy (SBRT) following surgery
Control group:Active monitoring after surgery, routine follow-up
Sponsors
Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Patients with histologically confirmed HCC following R0 resection; 3. Patients with primary HCC or recurrent HCC requiring reoperation within 2 years after curative surgery, where the investigator determines the lesion to be newly developed; 4. Minimum resection margin <1 cm; 5. Enhanced CT or MRI demonstrating no residual disease 4-6 weeks postoperatively; 6. Child-Pugh score 5-7; 7. ECOG PS 0-1; 8. Adequate blood counts and normal hepatic and renal function; 9. Willingness to comply with study and follow-up procedures; 10. Written informed consent obtained prior to any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Individuals with drug allergies; 2. Currently participating in interventional clinical research treatment; 3. Diagnosed with malignant diseases other than hepatocellular carcinoma within 3 years prior to first administration (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically excised carcinoma in situ); 4. Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other T-cell receptor stimulatory or co-inhibitory molecules (e.g., CTLA-4, OX-40, CD137); 5. History of solid organ or hematopoietic stem cell transplantation; 6. Patients receiving any neoadjuvant or conversion therapy prior to surgery. 7. Any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent >10 mg) or other immunosuppressive agents within 14 days prior to randomization; 8. Active autoimmune disease or history of autoimmune disease with potential for recurrence; 9. Evidence of idiopathic pulmonary fibrosis, organic pneumonia (e.g., obstructive bronchiolitis), or history of non-infectious pneumonia on screening chest CT scan; 10. Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for infection complications, bacteremia, or severe pneumonia; 11. Severe chronic or active infection (including tuberculosis) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to randomization; 12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive); untreated active hepatitis B; 13. Concurrent participation in another therapeutic clinical study; 14. Breastfeeding women, women of childbearing potential unwilling to use contraception; 15. Any other reason deemed inappropriate for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year disease-free survival rate;Median recurrence-free survival (RFS);Overall Survival(OS); | — |
Countries
China
Contacts
Public ContactYang Ning
Third Affiliated Hospital of Naval Medical University
Outcome results
None listed