Back to results

Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnoses of hepatocellular carcinoma based on EASL.
Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
Patients must have a performance status of ECOG score < 2.
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.
Patient must have serum creatinine < 1.5 mg/dl
Cardiac function with NYHA classification < Grade II
HBsAg (+) .
Signed informed consent.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone

Arm Description

Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.

Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.

Outcomes

Primary Outcome Measures

the 2-years recurrence rate

Two year recurrence rate between the two groups will be compared.

Secondary Outcome Measures

the 2-years recurrence-free survival

Two year recurrence-free survival between the two groups will be compared.

the 2-years overall survival.

Two year overall survival between the two groups will be compared.

Full Information

NCT ID

NCT03988998

First Posted

June 13, 2019

Last Updated

January 14, 2022

Sponsor

Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03988998

Brief Title

Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 10, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Radiofrequency Ablation with or without Radiotherapy

Masking

Outcomes Assessor

Masking Description

Outcomes (recurrence or death) Assessor is blind about the interventions.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency ablation with radiotherapy

Arm Type

Experimental

Arm Description

Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.

Arm Title

Radiofrequency ablation alone

Arm Type

Active Comparator

Arm Description

Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.

Intervention Type

Drug

Intervention Name(s)

Radiofrequency ablation with radiotherapy

Intervention Description

Radiofrequency ablation with radiotherapy

Intervention Type

Drug

Intervention Name(s)

Radiofrequency ablation alone

Intervention Description

Radiofrequency ablation without radiotherapy

Primary Outcome Measure Information:

Title

the 2-years recurrence rate

Description

Two year recurrence rate between the two groups will be compared.

Time Frame

2 year

Secondary Outcome Measure Information:

Title

the 2-years recurrence-free survival

Description

Two year recurrence-free survival between the two groups will be compared.

Time Frame

2 year

Title

the 2-years overall survival.

Description

Two year overall survival between the two groups will be compared.

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnoses of hepatocellular carcinoma based on EASL. Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm. Patients must have a performance status of ECOG score < 2. 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. Patient must have serum creatinine < 1.5 mg/dl Cardiac function with NYHA classification < Grade II HBsAg (+) . Signed informed consent. Exclusion Criteria: HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. Patients with advanced second primary malignancy are not eligible. Patients with pregnancy or breast-feeding are not eligible. Patients with severe cardiopulmonary diseases are not eligible. Patients with clinically significant psychiatric disorder are not eligible. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. Patients who had prior antitumor therapy for HCC are not eligible. Anti-HCV positive patients are not eligible.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhong Jian-Hong, PhD

Phone

0771-5301253

zhongjianhong@gxmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Bang-De, PhD

Phone

0771-5301253

xiangbangde@gxmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tang Wei-Zhong, PhD

Organizational Affiliation

Guangxi Medical University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26628466

Citation

Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.

Results Reference

background

PubMed Identifier

27709795

Citation

Seo YS, Kim MS, Yoo HJ, Jang WI, Paik EK, Han CJ, Lee BH. Radiofrequency ablation versus stereotactic body radiotherapy for small hepatocellular carcinoma: a Markov model-based analysis. Cancer Med. 2016 Nov;5(11):3094-3101. doi: 10.1002/cam4.893. Epub 2016 Oct 5.

Results Reference

background

PubMed Identifier

30805950

Citation

Hara K, Takeda A, Tsurugai Y, Saigusa Y, Sanuki N, Eriguchi T, Maeda S, Tanaka K, Numata K. Radiotherapy for Hepatocellular Carcinoma Results in Comparable Survival to Radiofrequency Ablation: A Propensity Score Analysis. Hepatology. 2019 Jun;69(6):2533-2545. doi: 10.1002/hep.30591. Epub 2019 May 2.

Results Reference

background

PubMed Identifier

30773192

Citation

Kim N, Kim HJ, Won JY, Kim DY, Han KH, Jung I, Seong J. Retrospective analysis of stereotactic body radiation therapy efficacy over radiofrequency ablation for hepatocellular carcinoma. Radiother Oncol. 2019 Feb;131:81-87. doi: 10.1016/j.radonc.2018.12.013. Epub 2018 Dec 31.

Results Reference

background

Learn more about this trial

Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs