Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

Prior treatment

• Possible surgical intervention;
• Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
• Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
• Currently participating in an interventional clinical trial treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first treatment;
• Previous treatment with anti-target tumor therapies;

Other illness

• Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;
• History of upper abdominal radiotherapy;

Other

• Severe liver dysfunction exceeding the specific criteria defined in the trial;
• Uncontrolled active comorbidities;
• Not meeting the expected survival prognosis or unable to provide informed consent.

• Prior to implementing any trial-related procedures, written informed consent must be signed;
• Age ≥ 18 years and ≤ 75 years;
• Child-Pugh score ≤ 7;KPS score ≥ 70;
• The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
• The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
• Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
• According to the criteria for evaluating the efficacy of solid tumors, there should be at least one measurable lesion by imaging, with the lesion size not exceeding 5 cm; total number of lesions ≤ 3;
• No previous anti-tumor treatment;
• Normal liver (liver volume minus tumor volume) is sufficient;
• Normal major organ functions, including blood routine tests \[absolute neutrophil count (ANC) ≥ 1.5 × 10\^9, platelets ≥ 70 × 10\^9, hemoglobin ≥ 80 g/L\], liver function tests \[bilirubin \< 3.0 mg/dL, international normalized ratio (INR) \< 1.7, albumin ≥ 2.8 g/dL, aspartate transaminase (AST)/alanine transaminase (ALT) \< 6\], serum creatinine \< 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL/min;
• Stable respiration for more than 10 minutes;
• Expected survival time \> 2 years.