NCT05433701

Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC

Active, enrolled NA Last updated 18 August 2023

What this trial tests

NA trial testing Stereotactic Body Radiotherapy in Hepatocellular Carcinoma in 178 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 August 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Jonggi Choi
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	29 August 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across South Korea

Drugs / interventions tested

• Stereotactic Body Radiotherapy
• Radiofrequency Ablation

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Jonggi Choi

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related mortality and the sixth most prevalent cancer in the world. Standard treatments for early-stage HCCs include resection, liver transplantation, and percutaneous ablation, with 5-year survival rates of over 50 percent. Less than one-third of patients, however, are candidates for hepatic resection, and the use of radiofrequency ablation (RFA) may be significantly limited in cases with unfavorable tumor location and poor visibility on images, which increase the risk of technical failures and complications after RFA.

Recent advancements in radiotherapy and imaging have made it possible to deliver optimal radiation doses on the tumor site while minimizing exposure to normal organs. Stereotactic body radiation therapy (SBRT) is a method of high-precision radiation therapy that concentrates high-dose radiation to HCC in a short period of time to maximize the therapeutic effect on the tumor and minimize the side effects on normal tissues. Prospective and retrospective studies on SBRT for HCC have demonstrated its efficacy for local tumor control in small HCC. On the basis of these promising clinical results, a number of studies have compared the efficacy of RFA and SBRT. However, there is no strong evidence from randomized controlled trials comparing SBRT and RFA.

In order to evaluate and compare the local efficacy and clinical outcomes of SBRT and RFA in patients with recurrent HCC, we conduct this non-inferiority trial.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Current Role of Stereotactic Body Radiation Therapy (SBRT) in Hepatocellular Carcinoma (HCC).
   Kimura T, Fujiwara T, Kameoka T, Adachi Y, et al · · 2022 · cited 36× · PMID 36139545 · DOI 10.3390/cancers14184383
2. Do We Have a Winner? Advocating for SBRT in HCC Management.
   Safavi AH, Dawson LA, Mesci A. · · 2024 · cited 6× · PMID 38380116 · DOI 10.1016/j.ctro.2024.100740
3. Local Therapies for Hepatocellular Carcinoma and Role of MRI-Guided Adaptive Radiation Therapy.
   Liu Y, Chou B, Yalamanchili A, Lim SN, et al · · 2023 · cited 6× · PMID 37240623 · DOI 10.3390/jcm12103517