Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Radiofrequency Ablation with or without Radiotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

Radiofrequency ablation with radiotherapy

Intervention Type DRUG

Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone

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

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation alone

Intervention Type DRUG

Radiofrequency ablation without radiotherapy

Interventions

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Radiofrequency ablation with radiotherapy

Intervention Type DRUG

Radiofrequency ablation alone

Radiofrequency ablation without radiotherapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No