MedTrace Logo

Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study

NCT05602974 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-02-17

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC or HCC located near liver capsule because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no adjuvant therapy after hepatectomy is generally considered to be effective in reducing post-operative recurrence.

Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. A large-sample and high-quality multi-center, randomized controlled, prospective study is warranted to further confirm the efficacy of adjuvant radiotherapy in patients with narrow margin resection, considering the small sample size of above-mentioned studies.

Conditions

Interventions

RADIATION

stereotactic body radiation therapy

adjuvant stereotactic body radiation therapy

OTHER

regular follow-up

regular follow-up

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Qichun Wei, MD/PhD · Zhejiang University

  • Weilin Wang, MD/PhD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602974 on ClinicalTrials.gov