Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

February 1, 2024 updated by: Beijing 302 Hospital

Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)

The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jing Sun, Master
  • Phone Number: +8613718681094 +8613718681094
  • Email: 519299998@qq.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm

Description

Inclusion Criteria:

  • primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
  • single lesion and longest tumor diameter ≤ 5.0 cm
  • CP-A or B classification
  • Eastern Cooperative Oncology Group (ECOG) score 0-1;
  • distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
  • unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
  • rejecting other therapies such as resection, liver transplantation, etc.
  • platelet count≥50 × 109/L, white blood count≥1.5 × 109/L
  • patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

  • tumor thrombus
  • lymph node involvement
  • extrahepatic metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SBRT with TACE
Procedure: transcatheter arterial chemoembolization
The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone.
SBRT alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rates
Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months
OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
From date of randomization until the date of death from any cause, assessed up to 36 months
Progression-free survival rates
Time Frame: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
Local control rates
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation-induced liver injury rates
Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction
Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Principal Investigator: Xuezhang Duan, PH.D, Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Actual)

December 11, 2023

Study Completion (Estimated)

January 11, 2025

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JingSun

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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