Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Radiofrequency ablation with radiotherapy; Drug: Radiofrequency ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03988998

FARTHER

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Radiofrequency ablation with radiotherapy

Experimental group

Description:

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

Treatment:

Drug: Radiofrequency ablation with radiotherapy

Radiofrequency ablation alone

Active Comparator group

Description:

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

Treatment:

Drug: Radiofrequency ablation alone