SBRT Versus Surgical Resection for Small HCC

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years, with no restriction on sex;

Clinically or pathologically diagnosed hepatocellular carcinoma, according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition);

A solitary tumor with a maximum diameter of ≤5 cm, for which treatment is indicated;

No radiologic evidence of macrovascular invasion, distant metastasis, or lymph node metastasis;

Disqualifiers

Severe dysfunction of major organs, including the heart, lungs, or kidneys; active infection other than viral hepatitis; or other serious concomitant conditions that preclude tolerance of either surgery or radiotherapy;

Contraindications to surgical resection or radiotherapy;

A history of other malignant tumors, with the exception of nonmelanoma skin cancer, carcinoma in situ of the cervix, or previously cured prostate cancer, nasopharyngeal carcinoma, breast cancer, or early-stage laryngeal cancer;

A history of multiple abdominal surgeries or liver or other solid-organ transplantation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    The SBRT dose ranges from 33 to 54 Gy and is delivered in three fractions on alternate days, with treatment completed within one week. This study enrolls patients with small hepatocellular carcinoma, defined as a solitary tumor with a maximum diameter of ≤5 cm, and compares the efficacy of SBRT with that of surgical resection.

  • Resection

    Procedure/Surgery

    Surgical resection serves as the control treatment in this study

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: ResectionActive comparator 1 intervention
Group B: SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

OS

time from random assignment to death from any cause

Time frame
time from random assignment to death from any cause, assessed up to 100 months

Secondary outcomes

1

PFS

time from random assignment to tumor progression or death fromany cause

Time frame
time from random assignment to tumor progression or death fromany cause, assessed up to 100 months
2

LPFS

time from random assignment to local tumor progression or death fromany cause

Time frame
time from random assignment to local tumor progression or death fromany cause, assessed up to 100 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.