About this trial
Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC or HCC located near liver capsule because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no adjuvant therapy after hepatectomy is generally considered to be effective in reducing post-operative recurrence.
Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. A large-sample and high-quality multi-center, randomized controlled, prospective study is warranted to further confirm the efficacy of adjuvant radiotherapy in patients with narrow margin resection, considering the small sample size of above-mentioned studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Have received radiotherapy for the area to be treated in the past;
Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
Extrahepatic metastasis;
Known history of active Bacillus Tuberculosis (TB)
Trial design
Parallel
Treatments tested in this trial
stereotactic body radiation therapy
Radiationadjuvant stereotactic body radiation therapy
regular follow-up
Other interventionregular follow-up
Treatment groups
Trial outcomes
Primary outcomes
marginal recurrence rate
1-year marginal recurrence rate
Secondary outcomes
Overall survival
3-year Overall survival
Recurrence free survival
3-year Recurrence free survival
Time to Progress
from date of enrollment to the date of progress. Assessed up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse events (CTCAE v5.0)
Sponsors and contacts
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