Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

NCT ID: NCT04891874

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2020-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SBRT group

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

Group Type: EXPERIMENTAL

Stereotactic radiotherapy

Intervention Type: RADIATION

Radiation using stereotactic radiotherapy device.

Surgery alone group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stereotactic radiotherapy

Radiation using stereotactic radiotherapy device.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

Changying Shi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiamei Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Secondary Military Medical Unversity, Shanghai

Locations

Second Military Medical University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35303509 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Eastern HSH

Identifier Type: -

Identifier Source: org_study_id