Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

NCT04891874 | Completed Results

• 1 other identifier: Eastern HSH
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Stereotactic body radiotherapy; Micro vascular invasion; Narrow resection margin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival (OS) Rate.

  OS rate at 5-years from randomization.

Other Outcomes (1)

• Number of Participants Occured Adverse Events(AE)

  AE will be evaluated up to 3 months after radiotherapy in SBRT group

Study Arms (2)

SBRT group

EXPERIMENTAL

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

Radiation: Stereotactic radiotherapy

Surgery alone group

NO INTERVENTION

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

Interventions

Stereotactic radiotherapy RADIATION

Radiation using stereotactic radiotherapy device.

SBRT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• spontaneous rupture;
• pathologically proved positive resection margin;
• severe cirrhosis with hypersplenism or esophageal and gastric varices;
• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Second Military Medical University

Shanghai, Shanghai Municipality, 200438, China

Location

Related Publications (1)

• 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.

  PMID: 35303509 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. SHI Changying
• Organization: Shanghai Eastern Hepatobiliary Surgery Hospital

nona-peach@hotmail.com

+86-021-81887735

Study Officials

• Jiamei Yang, MD

  Secondary Military Medical Unversity, Shanghai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Adjuvant SBRT after surgery group vs. surgery alone group.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: August 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 10, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)