Radiation vs. scalpel: landmark trial seeks best treatment for small liver tumors
NCT ID NCT07381660
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This phase 3 trial compares two treatments for small liver cancer (tumors 5 cm or smaller): surgery to remove the tumor or a precise, high-dose radiation therapy called SBRT. About 312 adults with a single liver tumor will be randomly assigned to one of the two treatments. The study aims to see which approach helps people live longer and with fewer side effects, providing clearer guidance for doctors and patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smart drug starve liver tumors without harming healthy tissue?
- Liver size may hold key to immunotherapy response
- Can a new model forecast liver cancer in hepatitis b?