SBRT Versus Surgical Resection for Small HCC

Inclusion criteria

• Age 18 to 75 years, with no restriction on sex;
• Clinically or pathologically diagnosed hepatocellular carcinoma, according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition);
• A solitary tumor with a maximum diameter of ≤5 cm, for which treatment is indicated;
• No radiologic evidence of macrovascular invasion, distant metastasis, or lymph node metastasis;
• Treatment-naïve or previously treated patients are eligible, provided that they are deemed suitable for both surgical resection and radiotherapy by a multidisciplinary team (MDT) and do not require concomitant systemic therapy at enrollment;
• For patients with recurrent disease, recurrence must occur at least 1 year after prior curative treatments;
• Previously treated patients must not have received systemic therapy within 6 months before enrollment;
• In previously treated patients, tumor size must be assessed according to RECIST version 1.1 at enrollment;
• A normal liver volume of ≥700 cc, with an estimated future liver remnant volume of >40% after resection;
• A Karnofsky performance-status score of ≥90;
• Child-Pugh class A liver function;
• An estimated life expectancy of more than 6 months;
• Adequate organ function, defined as follows: white-cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥75.0×10⁹/L, hemoglobin ≥90 g/L; serum albumin ≥28 g/L; total bilirubin ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase ≤2.5 times the ULN; serum creatinine ≤1.5 times the ULN or creatinine clearance >60 mL per minute; and no severe concomitant organic disease;
• The ability to understand the study procedures and to provide written informed consent before the initiation of any study-specific procedures, with agreement to receive treatment and follow-up according to the study protocol.

Exclusion criteria

• Severe dysfunction of major organs, including the heart, lungs, or kidneys; active infection other than viral hepatitis; or other serious concomitant conditions that preclude tolerance of either surgery or radiotherapy;
• Contraindications to surgical resection or radiotherapy;
• A history of other malignant tumors, with the exception of nonmelanoma skin cancer, carcinoma in situ of the cervix, or previously cured prostate cancer, nasopharyngeal carcinoma, breast cancer, or early-stage laryngeal cancer;
• A history of multiple abdominal surgeries or liver or other solid-organ transplantation;
• Previous radiotherapy to the upper abdomen;
• Pregnancy or breastfeeding;
• Any other condition that may interfere with patient enrollment or the assessment of study outcomes;
• Refusal to comply with the follow-up requirements of the study protocol or refusal to provide written informed consent.