Clinical trial NCT04891874: Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI
Official title: Adjuvant Stereotactic Body Radiation for Hepatocellular Carcinoma With Microvascular Invasion and Narrow Resection Margin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Stereotactic body radiotherapy
Micro vascular invasion
Narrow resection margin
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adjuvant SBRT after surgery group vs. surgery alone group.
Primary purpose: TREATMENT

Brief summary: Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to see if disease free survival and overall survival could be approved.

Detailed description: Hepatocellular carcinoma(HCC) ranks the 6th most common cancer and is the 2nd leading cause of cancer-related death globally. Surgical resection remains the most efficient therapy in early stage. Though an anatomical resection of tumor lead to an up to 70% 5-year overall survival, the existence of micro vascular invasion(MVI) caused early recurrence. Stereotactic body radiation therapy (SBRT) has been proved to be efficient in treating vascular tumor thrombosis. The investigators tried to implement this technique in adjuvant setting for HCC after surgery with MVI. Participants with early stage HCC whose tumor locates closely to the main intrahepatic vascular will be regarded as potentially-not-enough-surgical-margin candidates. Surgical resection will be carried out as scheduled and an additional silver clip will be put into the margin. Postoperative pathological examination will detect micro vascular invasion or daughter nodule. MVI-positive candidates will be eligible for enrollment. Eligible participants will be randomized to two groups, SBRT group and surgery-alone(SA) group with 1-to-1 ratio. Participants in SBRT group will receive a 35Gy limited resection margin parenchyma SBRT after surgery, while participants in SA group just get surgery. Radiation related adverse events (AE) or reaction will be recorded and intervened necessarily. All participants will be followed up by investigators every three months. DFS, OS, and AEs are end points in this study.

Eligibility criteria: Inclusion Criteria:

1. solitary nodule;
2. tumor adjacent to the main trunk of hepatic vein, cava vena, or to the major branch of portal vein (including the lobar branch at least);
3. macro-vascular negative;
4. no previous treatment before surgery;
5. no previous hepatic surgery;
6. Child-Pugh score A for hepatic function.

Exclusion Criteria:

1. spontaneous rupture;
2. pathologically proved positive resection margin;
3. severe cirrhosis with hypersplenism or esophageal and gastric varices;
4. 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver;
5. postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.

Primary outcomes:
measure: Participants Without Recurrence (Disease-free).
timeFrame: DFS rate at 5-years after randomization.
Secondary outcomes:
measure: Overall Survival (OS) Rate.
timeFrame: OS rate at 5-years from randomization.
Other outcomes:
measure: Number of Participants Occured Adverse Events(AE)
timeFrame: AE will be evaluated up to 3 months after radiotherapy in SBRT group
Locations:
city: Shanghai
country: China
facility: Second Military Medical University
state: Shanghai
Study officials:
affiliation: Secondary Military Medical Unversity, Shanghai
name: Jiamei Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi C, Li Y, Geng L, Shen W, Sui C, Dai B, Lu J, Pan M, Yang J. Adjuvant stereotactic body radiotherapy after marginal resection for hepatocellular carcinoma with microvascular invasion: A randomised controlled trial. Eur J Cancer. 2022 May;166:176-184. doi: 10.1016/j.ejca.2022.02.012. Epub 2022 Mar 15.