Liver NeoplasmsNCT07745153
Novel Abdominal Compression Positioning Technique for Respiratory Motion Management in Liver Tumors
An observational study of Liver Neoplasms and Carcinoma, Hepatocellular, run by Southern Medical University, China at 1 site in China.
Trial summary
1. Research Background The background of this study centers on stereotactic body radiation therapy (SBRT), an advanced form of radiotherapy that is short in duration, highly effective, and easy for patients to comply with. However, even small breathing movements can reduce its precision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Carcinoma, Hepatocellular
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 23 Jul 2026
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive radiotherapy at Nanfang Hospital, Southern Medical University and are diagnosed with primary liver cancer, as well as patients with liver metastases originating from other primary sites.
Who may be able to join
- Voluntarily signed informed consent.
- Age ≥ 18 years.
- Patients who require radiotherapy for liver cancer, as determined by the treating physician.
- Life expectancy > 3 months.
Who cannot join
- Discontinuation of radiotherapy or failure to complete the radiotherapy plan as prescribed.
- Presence of serious complications or comorbidities that may affect safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China
Guangzhou, Guangdong, 510515
About this study
- Research Background The background of this study centers on stereotactic body radiation therapy (SBRT), an advanced form of radiotherapy that is short in duration, highly effective, and easy for patients to comply with. However, even small breathing movements can reduce its precision. Abdominal compression devices have been proven to reduce respiratory motion and are now widely used in clinical practice. This study aims to determine whether a novel abdominal compression positioning technique can control tumor motion as effectively as current abdominal compression devices, whether it works better than traditional thermoplastic masks, and whether it can offer meaningful benefits to patients undergoing radiotherapy. These questions remain to be explored.
- Study Objectives The purpose of this study is to investigate how different immobilization devices affect the respiratory motion of liver tumors, in order to better assist with target delineation and the delivery of stereotactic body radiation therapy.
Read the detailed description
This study is a single-center, ambidirectional observational study.
- Conditions
- Liver Neoplasms, Carcinoma, Hepatocellular
- Keywords
- SBRT, liver tumor, abdominal compression
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal compression mask group（Experimental Arm） | Using the novel abdominal compression technique | |
| Thermoplastic body mask group（Control Arm） | Without the novel abdominal compression positioning technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor respiratory motion
Tumor respiratory motion amplitude
Measured: Within 1 week after completion of radiotherapy
Liver respiratory motion
Liver respiratory motion amplitude
Measured: Within 1 week after completion of radiotherapy
Secondary outcomes (1)
Local control rates
Status of local tumor control
Measured: Within one year after the completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jan 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
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
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiurui Ge, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745153
- Sponsor's protocol ID
- NFEC-202511-K15
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained from participants did not include provisions for sharing de-identified data outside the original research team. Sharing data under these circumstances would breach the ethical agreement made with the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Abdominal Compression Positioning Technique for Respiratory Motion Management in Liver Tumors
- ClinicalTrials.gov ID
- NCT07745153
- Acronym / sponsor ID
- NFEC-202511-K15
- Conditions
- Liver Neoplasms, Carcinoma, Hepatocellular
- Keywords
- SBRT, liver tumor, abdominal compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 4 Aug 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.
- Research Background The background of this study centers on stereotactic body radiation therapy (SBRT), an advanced form of radiotherapy that is short in duration, highly effective, and easy for patients to comply with. However, even small breathing movements can reduce its precision. Abdominal compression devices have been proven to reduce respiratory motion and are now widely used in clinical practice. This study aims to determine whether a novel abdominal compression positioning technique can control tumor motion as effectively as current abdominal compression devices, whether it works better than traditional thermoplastic masks, and whether it can offer meaningful benefits to patients undergoing radiotherapy. These questions remain to be explored.
- Study Objectives The purpose of this study is to investigate how different immobilization devices affect the respiratory motion of liver tumors, in order to better assist with target delineation and the delivery of stereotactic body radiation therapy.
Detailed description
This study is a single-center, ambidirectional observational study.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal compression mask group（Experimental Arm） | – | –Using the novel abdominal compression technique |
| Thermoplastic body mask group（Control Arm） | – | –Without the novel abdominal compression positioning technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive radiotherapy at Nanfang Hospital, Southern Medical University and are diagnosed with primary liver cancer, as well as patients with liver metastases originating from other primary sites.
Key inclusion criteria (4 listed)
- Voluntarily signed informed consent.
- Age ≥ 18 years.
- Patients who require radiotherapy for liver cancer, as determined by the treating physician.
- Life expectancy > 3 months.
Key exclusion criteria (2 listed)
- Discontinuation of radiotherapy or failure to complete the radiotherapy plan as prescribed.
- Presence of serious complications or comorbidities that may affect safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor respiratory motion
Time frame: Within 1 week after completion of radiotherapy
Tumor respiratory motion amplitude
Liver respiratory motion
Time frame: Within 1 week after completion of radiotherapy
Liver respiratory motion amplitude
1 secondary outcome
Local control rates
Time frame: Within one year after the completion of radiotherapy
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 4 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained from participants did not include provisions for sharing de-identified data outside the original research team. Sharing data under these circumstances would breach the ethical agreement made with the study participants.
Related trials for Liver Neoplasms
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
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 Carcinoma, Hepatocellular, run by Southern Medical University, China 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 4 inclusion and 2 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 4 Aug 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?
Tumor respiratory motion (time frame: Within 1 week after completion 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 4 Aug 2026.