NCT07381660

SBRT Versus Surgical Resection for Small HCC

Not yet recruiting Phase 3 Last updated 2 February 2026

What this trial tests

Phase 3 trial testing Stereotactic body radiotherapy (SBRT) in Hepatocellular Carcinoma (HCC) in 312 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
31 December 2031

31 December 2031

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	312
Start date	1 February 2026
Primary completion	31 December 2031
Estimated completion	31 December 2031

Drugs / interventions tested

• Stereotactic body radiotherapy (SBRT) — full drug profile →
• Resection

Conditions studied

• Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related incidence and mortality in China and represents a major public health challenge. Surgical resection is the most commonly used curative treatment for HCC and can provide favorable long-term outcomes. However, resection is associated with substantial perioperative morbidity, and its applicability is limited in certain patient populations, including those with recurrent disease, those who have undergone conversion therapy, and those with significant coexisting medical conditions.

Advances in radiotherapy technology and the development of highly precise delivery techniques have led to the increasing use of stereotactic body radiotherapy (SBRT) in the management of HCC, particularly in patients with small tumors. Randomized controlled trials conducted by our group have shown that, in patients with recurrent small HCC, SBRT provides superior local tumor control compared with radiofrequency ablation. These findings suggest that SBRT may represent a potentially curative treatment option for selected patients with small HCC.

On the basis of this evidence, the present study is designed to compare the efficacy and safety of surgical resection and SBRT in patients with small HCC. Patients with a solitary tumor measuring 5 cm or less in maximum diameter will be randomly assigned to undergo either surgical resection or SBRT. The primary end point of the study is overall survival. This trial aims to define the relative benefits and risks of these two treatment strategies and to provide high-quality evidence to inform clinical decision making and future guideline recommendations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.