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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 29, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called Stereotactic Body Radiotherapy (SBRT) for patients with hepatocellular carcinoma (HCC), a type of liver cancer. Specifically, the study is looking at patients who have undergone surgery to remove their cancer but have a narrow margin, meaning there is less than 1 centimeter of healthy tissue around the tumor. The goal is to see if adding SBRT after surgery can help reduce the chances of the cancer coming back. This trial is important because many patients with narrow margins have poorer survival rates, and there has not been a clear effective treatment after surgery to help them.

To participate in this study, patients need to be at least 18 years old and have a confirmed diagnosis of HCC with a narrow surgical margin. Other eligibility criteria include having adequate liver function and being in good overall health. Participants can expect to undergo SBRT, which is a targeted radiation treatment that usually takes a shorter time to complete than standard radiation therapy. Throughout the trial, they will be monitored closely for safety and effectiveness. This study aims to provide more evidence about the benefits of combining surgery with SBRT for improving outcomes in patients with this specific type of liver cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥18 years;
• • 2. 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;
• • 3. Pathologically confirmed as narrow margin (the shortest distance from the edge of the tumor to the surface of liver transection \<1cm) ;
• • 4. Child-Pugh class A and B7;
• • 5. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;
• • 6. Willing to provide tissue from an excisional biopsy of a tumor lesion;
• • 7. 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;
• 8. 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.
• Exclusion Criteria:
• • 1. Have received radiotherapy for the area to be treated in the past;
• • 2. Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
• • 3. Extrahepatic metastasis;
• • 4. Known history of active Bacillus Tuberculosis (TB)
• • 5. 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.
• • 6. Active infection requiring systemic therapy;
• • 7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
• • 8. Known psychiatric or substance abuse disorders ;
• • 9. Pregnant or breastfeeding;
• • 10. Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);
• • 11. Received a live vaccine within 30 days before radiotherapy.