Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

January 14, 2022 updated by: Jian-Hong Zhong, Guangxi Medical University

radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial

Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

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

Study Contact Backup

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnoses of hepatocellular carcinoma based on EASL.
  2. Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
  3. Patients must have a performance status of ECOG score < 2.

  4. Patients must have adequate liver reservation and adequate hemogram.

    • Pugh-Child's Score < 7.
    • The serum total bilirubin level are < 2 mg/dl.
    • The prothrombin times are < 3 sec above normal control.
    • The platelet are > 75 x 109/L.
  5. Patient must have serum creatinine < 1.5 mg/dl
  6. Cardiac function with NYHA classification < Grade II
  7. HBsAg (+) .
  8. Signed informed consent.

Exclusion Criteria:

  1. HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
  2. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
  3. Patients with advanced second primary malignancy are not eligible.
  4. Patients with pregnancy or breast-feeding are not eligible.
  5. Patients with severe cardiopulmonary diseases are not eligible.
  6. Patients with clinically significant psychiatric disorder are not eligible.
  7. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
  8. Patients who had prior antitumor therapy for HCC are not eligible.
  9. Anti-HCV positive patients are not eligible.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency ablation with radiotherapy
Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.
Drug: Radiofrequency ablation with radiotherapy
Radiofrequency ablation with radiotherapy
Active Comparator: Radiofrequency ablation alone
Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.
Drug: Radiofrequency ablation alone
Radiofrequency ablation without radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 2-years recurrence rate
Time Frame: 2 year
Two year recurrence rate between the two groups will be compared.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 2-years recurrence-free survival
Time Frame: 2 year
Two year recurrence-free survival between the two groups will be compared.
2 year
the 2-years overall survival.
Time Frame: 2 year
Two year overall survival between the two groups will be compared.
2 year

Collaborators and Investigators

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

Sponsor

Guangxi Medical University

Investigators

  • Study Chair: Tang Wei-Zhong, PhD, Guangxi Medical University

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 (Anticipated)

January 10, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 15, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FARTHER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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