SBRT vs surgical removal for small liver cancer (HCC)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares SBRT to surgical resection in adults with a solitary HCC tumor measuring 5 cm or less and no vascular invasion or distant spread. Eligible participants must be suitable for both treatments as judged by a multidisciplinary team and may be treatment-naïve or previously treated, with no recent systemic therapy. The trial aims to determine local tumor control and other clinical outcomes between the two approaches using standardized criteria. Prior data from similar settings suggest SBRT may offer favorable control with lower perioperative risk for select patients. The study is led by Sun Yat-sen University and conducted at its Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 75 years, with no restriction on sex;
2. Clinically or pathologically diagnosed hepatocellular carcinoma, according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition);
3. A solitary tumor with a maximum diameter of ≤5 cm, for which treatment is indicated;
4. No radiologic evidence of macrovascular invasion, distant metastasis, or lymph node metastasis;
5. Treatment-naïve or previously treated patients are eligible, provided that they are deemed suitable for both surgical resection and radiotherapy by a multidisciplinary team (MDT) and do not require concomitant systemic therapy at enrollment;
6. For patients with recurrent disease, recurrence must occur at least 1 year after prior curative treatments;
7. Previously treated patients must not have received systemic therapy within 6 months before enrollment;
8. In previously treated patients, tumor size must be assessed according to RECIST version 1.1 at enrollment;
9. A normal liver volume of ≥700 cc, with an estimated future liver remnant volume of \>40% after resection;
10. A Karnofsky performance-status score of ≥90;
11. Child-Pugh class A liver function;
12. An estimated life expectancy of more than 6 months;
13. Adequate organ function, defined as follows: white-cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥75.0×10⁹/L, hemoglobin ≥90 g/L; serum albumin ≥28 g/L; total bilirubin ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase ≤2.5 times the ULN; serum creatinine ≤1.5 times the ULN or creatinine clearance \>60 mL per minute; and no severe concomitant organic disease;
14. The ability to understand the study procedures and to provide written informed consent before the initiation of any study-specific procedures, with agreement to receive treatment and follow-up according to the study protocol.

Exclusion Criteria:

1. 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;
2. Contraindications to surgical resection or radiotherapy;
3. 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;
4. A history of multiple abdominal surgeries or liver or other solid-organ transplantation;
5. Previous radiotherapy to the upper abdomen;
6. Pregnancy or breastfeeding;
7. Any other condition that may interfere with patient enrollment or the assessment of study outcomes;
8. Refusal to comply with the follow-up requirements of the study protocol or refusal to provide written informed consent.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Minshan Chen, PhD, MD
• Email: chenmsh@sysucc.org.cn
• Phone: +86 13902241061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.