Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03988998
• Other study ID #: FARTHER
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 10, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2022
• Source: Guangxi Medical University
• Contact: Zhong Jian-Hong, PhD
• Phone: 0771-5301253
• Email: zhongjianhong[@]gxmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Radiofrequency ablation with radiotherapy
Radiofrequency ablation with radiotherapy
• Radiofrequency ablation alone
Radiofrequency ablation without radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 2-years recurrence rate	Two year recurrence rate between the two groups will be compared.	2 year
Secondary	the 2-years recurrence-free survival	Two year recurrence-free survival between the two groups will be compared.	2 year
Secondary	the 2-years overall survival.	Two year overall survival between the two groups will be compared.	2 year