Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

Hepatocellular Carcinoma Clinical Trial

Official title:

Adjuvant Stereotactic Body Radiation for Hepatocellular Carcinoma With Microvascular Invasion and Narrow Resection Margin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891874
• Other study ID #: Eastern HSH
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 a-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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Stereotactic radiotherapy
Radiation using stereotactic radiotherapy device.

Locations

Country	Name	City	State
China	Second Military Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Occured Adverse Events(AE)	AE was defined as side effect related to the radiotherapy	AE will be evaluated up to 3 months after radiotherapy in SBRT group
Primary	Participants Without Recurrence (Disease-free).	Participants will be monitored for recurrence(disease) since enrollment. DFS was defined as time interval from randomization to the first recurrence. The unit of measure was month.	DFS rate at 5-years after randomization.
Secondary	Overall Survival (OS) Rate.	OS was defined as time interval from randomization to death.	OS rate at 5-years from randomization.