Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03988998

Enrollment

100

Registered

2019-06-18

Start date

2022-01-10

Completion date

2023-01-31

Last updated

2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DRUGRadiofrequency ablation with radiotherapy

Radiofrequency ablation with radiotherapy

DRUGRadiofrequency ablation alone

Radiofrequency ablation without radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

Radiofrequency Ablation with or without Radiotherapy

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactZhong Jian-Hong, PhD

zhongjianhong@gxmu.edu.cn0771-5301253

Backup ContactXiang Bang-De, PhD

xiangbangde@gxmu.edu.cn0771-5301253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026