Clinical trial NCT04434989: SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma
Official title: Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year local recurrence rate
timeFrame: 1 year
measure: Disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: 2-year recurrence rate
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: 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.
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 Jul;73(1):121-129. doi: 10.1016/j.jhep.2020.03.005. Epub 2020 Mar 10.
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.
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.