Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study

Prior treatment

• Have received radiotherapy for the area to be treated in the past;
• Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
• Received a live vaccine within 30 days before radiotherapy.

Other illness

• Known history of active Bacillus Tuberculosis (TB)
• Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
• Active infection requiring systemic therapy;
• Known psychiatric or substance abuse disorders ;
• Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);

Other

• Extrahepatic metastasis;
• Pregnant or breastfeeding;

• Aged ≥18 years;
• Confirmed diagnosis of HCC. The diagnosis can be established radiographically by the criteria of the American Association for the Study of the Liver (AASLD), or by histologic diagnosis from the core biopsy;
• Pathologically confirmed as narrow margin (the shortest distance from the edge of the tumor to the surface of liver transection \<1cm) ;
• Child-Pugh class A and B7;
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
• Willing to provide tissue from an excisional biopsy of a tumor lesion;
• For patients with active HBV: HBV DNA \< 2000 IU/mL during screening, and have initiated anti-HBV treatment at least 7 days prior to SBRT and willingness to continue anti-HBV treatment during the study;
• Adequate organ and marrow function as defined below:
  • 1)Marrow: absolute neutrophil count ≥1.5×109/L; platelets ≥50×109/L; hemoglobin ≥90g/L; 2)Liver: total bilirubin ≤3× institutional upper limit of normal (ULN); AST(aspartate aminotransferase) or ALT(alanine aminotransferase) ≤ 5× institutional ULN; albumin ≥29g/L; 3)Kidney: creatinine ≤ 1.5× institutional ULN or estimated glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 (according to the Cockcroft-Gault formula); 9. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 30 days after radiotherapy. Female patient of childbearing potential should have a negative serum pregnancy test before 72h of her first treatment. Sexually active males must agree to use an adequate method of contraception starting with the treatment through 4 months after radiotherapy.