Adjuvant Stereotactic Body Radiation for Hepatocellular Carcinoma With Microvascular Invasion and Narrow Resection Margin
Phase: NA
Conditions: Hepatocellular Carcinoma
Sponsor: Eastern Hepatobiliary Surgery Hospital

 
 
 
 
Adjuvant Radiotherapy for Resected 
Hepatocellular Carcinoma With MVI 
 
 
 
NCT 04891874 
2015-8-1 
 
 

 
Objectives: Marginal resection frequently occurred in hepatectomy for hepatocellular 
carcinoma (HCC), which led to increased local recurrence, especially among patients 
with microvascular invasion (MVI). Stereotactic body radiotherapy (SBRT) shows 
effective in tumor controlling, while limited research reported the efficacy of SBRT as 
adjuvant setting for HCC. This prospective randomized controlled study aims to 
investigate the efficacy of SBRT as adjuvant setting for HCC patients with MVI and 
positive resection margin. 
Design: This is a single center, prospective, randomized controlled clinical trial 
measuring the efficacy of SBRT as adjuvant therapy for early HCC with MVI after 
surgery. 
Methods: Participants with HCC and MVI receiving marginal resection were 
randomly assigned to postoperative adjuvant SBRT group or surgery alone (SA) 
group. Patients in SBRT group received SBRT targeting on the resection marginal 
parenchyma one month after surgery. The disease-free survival (DFS) and overall 
survival (OS) were compared between the groups and the adverse events (AE) in the 
SBRT group were recorded. 
 
Protocol 
1. Adult patients diagnosed with hepatocellular carcinoma, suitable for partial 
hepatectomy were considered as potential candidates while the patients were 
referred to hospital (n=263). 
2. In-hospital examination includes physical status, liver function and tumor stage. 
Patients with Child-Pugh A liver function, ECOG physical status 0/1, and 
BCLC stage 0/A were good candidates for surgical resection. These patients 
would be put forward to surgery and waiting for the postoperative pathological 
examination. Marginal resection was applied while tumor was adjacent to 
major vasculature or severe cirrhosis existed. We routinely mark the unsafe 
resection margin with silver clips for potential adjuvant postoperative therapy. 
3. Once pathological examination proved micro-vascular invasion in paratumoral 
tissue, which meant a higher incidence of early recurrence for the patient, the 
patient would be considered as a candidate for enrollment. 
4. The protocol and detail of the trial would be clearly explained to the patient and 
the written informed consent were collected if the patient agreed to be enrolled. 
5. Randomization: Randomization was carried out using the random sequence 
method of EXCEL, keeping a 1:1 ratio in groups. Two nurses on daily duty 
accomplished the randomization and allocation work. Participants in SBRT 
group would be sent to a separate team of radiologists who carried out the 
radiotherapy and follow-up survey (n=76). 
6. Concealment: Concealment was not attached in the SBRT group and blinding was 
not applied due to the SBRT procedure. 
7. Surgery: The conventional open partial hepatectomy was applied in this study. 
After removal of the tumor, silver clips were imbedded to mark where resection 

margin was narrow and absent. The marginal liver resection was defined as the 
minimal distance from tumor edge to the cut surface ＜5mm, regardless of the 
margin was positive or not. 
8. Radiotherapy：SBRT was delivered by the CyberKnife® system (Accuracy Inc., 
Sunnyvale, CA, USA) with tumor tracking devices. All the patients received 
fiducial marker implantation in operation for the tumor tracking technique. 
9. Follow-up: All the participants received follow-up every 3 months until 
recurrence or censored.