Hepatocellular Carcinoma (HCC)Phase 3NCT07381660
SBRT Versus Surgical Resection for Small HCC
A Phase 3 study testing Stereotactic body radiotherapy (SBRT) and Resection in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Stereotactic body radiotherapy (SBRT) and Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 31 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- For patients with recurrent disease, recurrence must occur at least 1 year after prior curative treatments;
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- Previously treated patients must not have received systemic therapy within 6 months before enrollment;
- In previously treated patients, tumor size must be assessed according to RECIST version 1.1 at enrollment;
- A normal liver volume of ≥700 cc, with an estimated future liver remnant volume of >40% after resection;
- A Karnofsky performance-status score of ≥90;
- Child-Pugh class A liver function;
- An estimated life expectancy of more than 6 months;
- 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;
- 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.
Who cannot join
- 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;
- Previous radiotherapy to the upper abdomen;
- Pregnancy or breastfeeding;
- Any other condition that may interfere with patient enrollment or the assessment of study outcomes;
- Refusal to comply with the follow-up requirements of the study protocol or refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yaojun Zhang, PhD, MD contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yaojun Zhang, +86 13719433968, zhangyuj@sysucc.org.cn
About this study
Official title: Stereotactic Body Radiotherapy (SBRT) Versus Surgical Resection in Patients With Small Hepatocellular Carcinoma: A Phase III, Open-label, Randomized Controlled 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Stereotactic body radiotherapy (SBRT), Resection
- Keywords
- HCC, SBRT, Resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ResectionProcedure or surgery
Surgical resection serves as the control treatment in this study
| Study group | Role | What they receive |
|---|---|---|
| Resection | Active comparator | Patient receive surgical resection Receives: Procedure: Resection |
| SBRT | Experimental | Patient receive SBRT Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
time from random assignment to death from any cause
Measured: time from random assignment to death from any cause, assessed up to 100 months
Secondary outcomes (2)
PFS
time from random assignment to tumor progression or death fromany cause
Measured: time from random assignment to tumor progression or death fromany cause, assessed up to 100 months
LPFS
time from random assignment to local tumor progression or death fromany cause
Measured: time from random assignment to local tumor progression or death fromany cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start18 Mar 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Min-Shan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381660
- Sponsor's protocol ID
- B2025-806-01
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are available from the corresponding author (Minshan Chen and Yaojun Zhang) by request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) Versus Surgical Resection in Patients With Small Hepatocellular Carcinoma: A Phase III, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07381660
- Acronym / sponsor ID
- B2025-806-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, SBRT, Resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection | Active comparator | Procedure: ResectionPatient receive surgical resection |
| SBRT | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)Patient receive SBRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
- 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;
Key exclusion criteria (8 listed)
- 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;
- Previous radiotherapy to the upper abdomen;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)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. | Radiation | SBRT |
| ResectionSurgical resection serves as the control treatment in this study | Procedure or surgery | Resection |
Primary outcome
OS
Time frame: time from random assignment to death from any cause, assessed up to 100 months
time from random assignment to death from any cause
2 secondary outcomes
PFS
Time frame: time from random assignment to tumor progression or death fromany cause, assessed up to 100 months
LPFS
Time frame: time from random assignment to local tumor progression or death fromany cause, assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. IPD are available from the corresponding author (Minshan Chen and Yaojun Zhang) by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaojun Zhang, PhD, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic body radiotherapy (SBRT) and Resection in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minshan Chen, PhD, MD (+86 13902241061, chenmsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: time from random assignment to death from any cause, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.