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Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Stereotactic body radiotherapy, Micro vascular invasion, Narrow resection margin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SBRT group

Surgery alone group

Arm Description

Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.

Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS) Rate.
OS was defined as time interval from randomization to death.

Full Information

First Posted
May 12, 2021
Last Updated
August 14, 2021
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04891874
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Stereotactic body radiotherapy, Micro vascular invasion, Narrow resection margin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adjuvant SBRT after surgery group vs. surgery alone group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT group
Arm Type
Experimental
Arm Description
Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.
Arm Title
Surgery alone group
Arm Type
No Intervention
Arm Description
Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Radiation using stereotactic radiotherapy device.
Primary Outcome Measure Information:
Title
Participants Without Recurrence (Disease-free).
Description
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.
Time Frame
DFS rate at 5-years after randomization.
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Rate.
Description
OS was defined as time interval from randomization to death.
Time Frame
OS rate at 5-years from randomization.
Other Pre-specified Outcome Measures:
Title
Number of Participants Occured Adverse Events(AE)
Description
AE was defined as side effect related to the radiotherapy
Time Frame
AE will be evaluated up to 3 months after radiotherapy in SBRT group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: solitary nodule; 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); macro-vascular negative; no previous treatment before surgery; no previous hepatic surgery; Child-Pugh score A for hepatic function. Exclusion Criteria: spontaneous rupture; pathologically proved positive resection margin; severe cirrhosis with hypersplenism or esophageal and gastric varices; 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver; postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiamei Yang, MD
Organizational Affiliation
Secondary Military Medical Unversity, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35303509
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.
Results Reference
derived

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Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

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