SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— SAIL  

Official title:

Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434989
• Other study ID #: HCC2020
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.

Description:

The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients will be randomized into SBRT group and RFA group as 1:1 ratio.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment.

2. Unifocal tumor =5cm

3. Closed to great vessels (diameter =3mm)

4. ECOG score 0-1

5. Child-Pugh grade A or B7

6. Sufficient liver and kidney function

Exclusion Criteria:

1. Vascular invasion

2. Extra-hepatic metastasis

3. Received TACE before

4. Inflammation of local skin

5. Dysfunction of liver, kidney or bone marrow.

6. Concomitant other malignant tumor or HIV infection

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
SBRT for perivascular HCC

Procedure:
• radiofrequency ablation
RFA for perivascular HCC

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

Kang TW, Lim HK, Lee MW, Kim YS, Choi D, Rhim H. Perivascular versus nonperivascular small HCC treated with percutaneous RF ablation: retrospective comparison of long-term therapeutic outcomes. Radiology. 2014 Mar;270(3):888-99. doi: 10.1148/radiol.13130753. Epub 2013 Nov 22. — View Citation

Kim N, Cheng J, Jung I, Liang J, Shih YL, Huang WY, Kimura T, Lee VHF, Zeng ZC, Zhenggan R, Kay CS, Heo SJ, Won JY, Seong J. Stereotactic body radiation therapy vs. radiofrequency ablation in Asian patients with hepatocellular carcinoma. J Hepatol. 2020 Mar 10. pii: S0168-8278(20)30163-X. doi: 10.1016/j.jhep.2020.03.005. [Epub ahead of print] — View Citation

Rajyaguru DJ, Borgert AJ, Smith AL, Thomes RM, Conway PD, Halfdanarson TR, Truty MJ, Kurup AN, Go RS. Radiofrequency Ablation Versus Stereotactic Body Radiotherapy for Localized Hepatocellular Carcinoma in Nonsurgically Managed Patients: Analysis of the National Cancer Database. J Clin Oncol. 2018 Feb 20;36(6):600-608. doi: 10.1200/JCO.2017.75.3228. Epub 2018 Jan 12. — 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	1-year local recurrence rate	The rate of participants who have recurrence in treating area in 1 year to all the participants	1 year
Primary	Disease-free survival	The duration between radomization and recurrence, progression or death	2 years
Secondary	Overall survival	The duration between radomization and death	2 years
Secondary	2-year recurrence rate	The rate of participants who have recurrence in 2 years to all the participants	2 years
Secondary	Adverse events	The incidence rate of severe adverse events	2 years