Liver NeoplasmsNCT07346573
Radiotherapy Safety for Liver Malignancies Using Post-Treatment Imaging
An observational study of Liver Neoplasms and Radiation-Induced Liver Injury, run by Cao peiguo at 1 site in China.
Trial summary
The goal of this retrospective observational study is to investigate the safety of radiation therapy for liver malignancies by analyzing data from patients who have already completed this treatment . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Neoplasms, Radiation-Induced Liver Injury
- What is being tested?
- Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with primary or metastatic liver malignancies who received liver radiotherapy (e.g., SBRT or IMRT) at the Third Xiangya Hospital of Central South University between July 2015 and September 2024 , and had complete dosimetric data and follow-up CT imaging available for retrospective analysis.
Who may be able to join
- Primary or secondary liver malignancies, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and secondary liver tumors.
- Liver function of Child-Pugh classification A or B.
- Completed EBRT treatment as planned.
- No other local treatment of liver lesions between EBRT and the follow-up imaging examination.
- Complete imaging re-examination data.
- Three-phase enhancement CT scans showing typical Focal Liver Reaction (FLR).
- The registration effect of follow-up CT and planning CT is satisfactory.
Who cannot join
- History of upper abdominal radiotherapy or liver transplantation.
- Failure to complete radiotherapy as scheduled.
- Previous cancer treatment-related toxicities that did not return to baseline or grade 0-1 (except for hair loss and peripheral neuropathy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Single-Center Study Utilizing AI-Based Radiomics on Pre- and Post-Radiotherapy CT Images to Explore the Safety Dose Threshold in Liver Malignancy Radiation Therapy
The goal of this retrospective observational study is to investigate the safety of radiation therapy for liver malignancies by analyzing data from patients who have already completed this treatment . The main questions it aims to answer are:
What is the specific radiation dose level that leads to a visible change on CT scans called a Focal Liver Reaction (FLR)? Why do some patients develop these imaging changes while others do not, based on their scan features and clinical information? Researchers will compare patients who developed FLR with those who did not to identify the factors associated with this reaction.
This study uses existing medical records and images; therefore, participants will not need to undergo any new interventions or procedures.
- Conditions
- Liver Neoplasms, Radiation-Induced Liver Injury
- Being tested
- Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver CancerOther
This is a retrospective observational study. The intervention (radiotherapy) was administered as part of standard clinical care prior to the study. Researchers are analyzing the outcomes of this previously delivered intervention.
| Study group | Role | What they receive |
|---|---|---|
| FLR Group | Patients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy Receives: Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer | |
| Non-FLR Group | Patients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy Receives: Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Threshold for Focal Liver Reaction (FLR)
The minimum radiation dose (in Gy) required to induce a radiologically visible Focal Liver Reaction (FLR) on follow-up CT imaging, as assessed by CT scan.
Measured: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
Predictors of FLR Susceptibility
Differences in radiomic features and clinical baseline characteristics (e.g., age, gender, liver function, and tumor size) between patients with radiologically confirmed Focal Liver Reaction (FLR) and those without, assessed by radiomic analysis and clinical data review.
Measured: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 May 2019
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cao peiguo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cao peiguo, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346573
- Sponsor's protocol ID
- CSU-2024-HCCRT001
- Status last verified
- May 2025
- First submitted
- 15 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Single-Center Study Utilizing AI-Based Radiomics on Pre- and Post-Radiotherapy CT Images to Explore the Safety Dose Threshold in Liver Malignancy Radiation Therapy
- ClinicalTrials.gov ID
- NCT07346573
- Acronym / sponsor ID
- CSU-2024-HCCRT001
- Conditions
- Liver Neoplasms, Radiation-Induced Liver Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Cao peiguoUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jan 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.
The goal of this retrospective observational study is to investigate the safety of radiation therapy for liver malignancies by analyzing data from patients who have already completed this treatment . The main questions it aims to answer are:
What is the specific radiation dose level that leads to a visible change on CT scans called a Focal Liver Reaction (FLR)? Why do some patients develop these imaging changes while others do not, based on their scan features and clinical information? Researchers will compare patients who developed FLR with those who did not to identify the factors associated with this reaction.
This study uses existing medical records and images; therefore, participants will not need to undergo any new interventions or procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLR Group | – | Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver CancerPatients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy |
| Non-FLR Group | – | Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver CancerPatients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with primary or metastatic liver malignancies who received liver radiotherapy (e.g., SBRT or IMRT) at the Third Xiangya Hospital of Central South University between July 2015 and September 2024 , and had complete dosimetric data and follow-up CT imaging available for retrospective analysis.
Key inclusion criteria (7 listed)
- Primary or secondary liver malignancies, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and secondary liver tumors.
- Liver function of Child-Pugh classification A or B.
- Completed EBRT treatment as planned.
- No other local treatment of liver lesions between EBRT and the follow-up imaging examination.
- Complete imaging re-examination data.
Key exclusion criteria (3 listed)
- History of upper abdominal radiotherapy or liver transplantation.
- Failure to complete radiotherapy as scheduled.
- Previous cancer treatment-related toxicities that did not return to baseline or grade 0-1 (except for hair loss and peripheral neuropathy).
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 |
|---|---|---|
| Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver CancerThis is a retrospective observational study. The intervention (radiotherapy) was administered as part of standard clinical care prior to the study. Researchers are analyzing the outcomes of this previously delivered intervention. | Other | FLR Group, Non-FLR Group |
Primary outcome
Dose Threshold for Focal Liver Reaction (FLR)
Time frame: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
The minimum radiation dose (in Gy) required to induce a radiologically visible Focal Liver Reaction (FLR) on follow-up CT imaging, as assessed by CT scan.
Predictors of FLR Susceptibility
Time frame: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
Differences in radiomic features and clinical baseline characteristics (e.g., age, gender, liver function, and tumor size) between patients with radiologically confirmed Focal Liver Reaction (FLR) and those without, assessed by radiomic analysis and clinical data review.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Radiation-Induced Liver Injury, run by Cao peiguo 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Threshold for Focal Liver Reaction (FLR) (time frame: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy). The study lists 2 primary outcomes in all. 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 16 Jan 2026.