Primary Liver CancersNCT07211815
Dosimetric Differences and Clinical Significance Analysis Between Body Gamma Knife and VMAT Radiotherapy for Primary Liver Cance
An observational study of Primary Liver Cancers, run by Chifeng Tumor Hospital at 1 site in China.
Trial summary
To fill in the "Brief Summary" field, you need to provide clear, easy-to-understand information about the study for patients, families, and healthcare providers. Here's a suggested summary: This study compares the dosimetric features and clinical effects of body gamma knife and VMAT radiotherapy for locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Liver Cancers
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Jun 2027
- Phase
- Observational
- 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
Study population: Patients with locally advanced primary liver cancer (unsuitable for/refusing surgery, meeting inclusion \& not exclusion criteria), aged 18-75 years, from Chifeng Tumor Hospital.
Who may be able to join
- Aged 18-75 years.
- Clinically or pathologically confirmed primary liver cancer; unsuitable for or - refusing surgery, with single tumor diameter ≤5 cm and ≤5 nodules.
- ECOG PS score 0-1.
- Liver function: Child-Pugh grade A or B.
- Prothrombin time (PT) < 4 seconds above the normal control range.
- No hepatic encephalopathy or moderate to large ascites.
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- Renal and cardiopulmonary function basically normal.
- Gastroscopy findings: no severe esophageal varices or active peptic ulcer.
- Hemoglobin ≥90 g/L, WBC ≥3.0×10⁹/L, neutrophil ≥1.5×10⁹/L, platelet ≥40×10⁹/L.
- No obvious cachexia; life expectancy > 3 months.
- Not pregnant; no HIV or syphilis infection.
- Able to understand the study and sign informed consent.
Who cannot join
- History of portal hypertension, esophageal variceal bleeding, or related conditions.
- History of anti-RHCC treatment or spontaneous tumor rupture.
- Postoperative pathology indicates metastatic cancer or other primary cancers.
- Cerebrovascular accident within 6 months before enrollment.
- Severe lung disease; serum creatinine > 1.25×the upper normal limit.
- Poorly controlled acute or active infection; severe mental illness.
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- Suspected systemic or local lymphadenopathy on imaging.
- Pregnant or lactating women; presence of other serious underlying diseases.
- Currently participating in other clinical trials; refusal to provide 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.
China1 site
Chifeng Tumor Hospital
Chifeng, Inner Mongolia, 024000
Jiarui Zhang, +8615049640955, rad_zhangjiarui@163.com
About this study
To fill in the "Brief Summary" field, you need to provide clear, easy-to-understand information about the study for patients, families, and healthcare providers. Here's a suggested summary:
This study compares the dosimetric features and clinical effects of body gamma knife and VMAT radiotherapy for locally advanced primary liver cancer. We retrospectively analyze 20 patients from Chifeng Tumor Hospital who cannot or refuse surgery. For each patient, we will develop both body gamma knife and VMAT radiotherapy plans. Then, we'll compare the dose distribution in the tumor target (including conformity index and homogeneity index) and the radiation exposure to organs at risk (such as the spinal cord, stomach, and liver). The goal is to find out which radiotherapy approach is more beneficial, so patients, families, and healthcare teams can better understand how this research supports treatment decisions.
- Conditions
- Primary Liver Cancers
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 |
|---|---|---|
| Gamma Knife Treatment Group | Patients in this group receive body gamma knife radiotherapy. The treatment utilizes fixed radiation sources, and the treatment couch moves to each treatment target. A 50% isodose curve covers at least 95% of the Planning Target Volume (PTV), and this modality is applied for radiotherapy of locally advanced primary liver cancer. | |
| Accelerator Treatment Group | Patients in this group receive radiotherapy with an accelerator (applying VMAT technology). Based on the tumor's location and surrounding organs at risk, beam angles and the number of fields are selected. The prescription dose curve covers 95% of the Planning Target Volume (PTV), and this method is used for radiotherapy of locally advanced primary liver cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the conformity index (a dosimetric measure of how well radiation conforms to the target volume) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Secondary outcomes (5)
Gradient Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the gradient index (a dosimetric measure of dose fall-off outside the target volume) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Homogeneity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the homogeneity index (a dosimetric measure of dose uniformity within the target volume) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Liver V20 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the volume of liver receiving 20 Gy (V20) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Liver Mean Dose (Dmean) Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the mean dose (Dmean) to the liver between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Liver V5 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Compare the volume of liver receiving 5 Gy (V5) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
Measured: Within 1 month after completion of radiotherapy planning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancersStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chifeng Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211815
- Sponsor's protocol ID
- CFSZLYY - FLK - 2025 - 001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Differences and Clinical Significance Analysis Between Body Gamma Knife and VMAT Radiotherapy for Primary Liver Cance
- ClinicalTrials.gov ID
- NCT07211815
- Acronym / sponsor ID
- CFSZLYY - FLK - 2025 - 001
- Conditions
- Primary Liver Cancers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chifeng Tumor HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
To fill in the "Brief Summary" field, you need to provide clear, easy-to-understand information about the study for patients, families, and healthcare providers. Here's a suggested summary:
This study compares the dosimetric features and clinical effects of body gamma knife and VMAT radiotherapy for locally advanced primary liver cancer. We retrospectively analyze 20 patients from Chifeng Tumor Hospital who cannot or refuse surgery. For each patient, we will develop both body gamma knife and VMAT radiotherapy plans. Then, we'll compare the dose distribution in the tumor target (including conformity index and homogeneity index) and the radiation exposure to organs at risk (such as the spinal cord, stomach, and liver). The goal is to find out which radiotherapy approach is more beneficial, so patients, families, and healthcare teams can better understand how this research supports treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma Knife Treatment Group | – | –Patients in this group receive body gamma knife radiotherapy. The treatment utilizes fixed radiation sources, and the treatment couch moves to each treatment target. A 50% isodose curve covers at least 95% of the Planning Target Volume (PTV), and this modality is applied for radiotherapy of locally advanced primary liver cancer. |
| Accelerator Treatment Group | – | –Patients in this group receive radiotherapy with an accelerator (applying VMAT technology). Based on the tumor's location and surrounding organs at risk, beam angles and the number of fields are selected. The prescription dose curve covers 95% of the Planning Target Volume (PTV), and this method is used for radiotherapy of locally advanced primary liver cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced primary liver cancer (unsuitable for/refusing surgery, meeting inclusion \& not exclusion criteria), aged 18-75 years, from Chifeng Tumor Hospital.
Key inclusion criteria (12 listed)
- Aged 18-75 years.
- Clinically or pathologically confirmed primary liver cancer; unsuitable for or - refusing surgery, with single tumor diameter ≤5 cm and ≤5 nodules.
- ECOG PS score 0-1.
- Liver function: Child-Pugh grade A or B.
- Prothrombin time (PT) < 4 seconds above the normal control range.
Key exclusion criteria (9 listed)
- History of portal hypertension, esophageal variceal bleeding, or related conditions.
- History of anti-RHCC treatment or spontaneous tumor rupture.
- Postoperative pathology indicates metastatic cancer or other primary cancers.
- Cerebrovascular accident within 6 months before enrollment.
- Severe lung disease; serum creatinine > 1.25×the upper normal limit.
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
Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
Compare the conformity index (a dosimetric measure of how well radiation conforms to the target volume) between body gamma knife and VMAT radiotherapy in patients with locally advanced primary liver cancer.
5 secondary outcomes
Gradient Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
Homogeneity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
Liver V20 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
Liver Mean Dose (Dmean) Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
Liver V5 Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer
Time frame: Within 1 month after completion of radiotherapy planning
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 8 Oct 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Primary Liver Cancers, run by Chifeng Tumor Hospital 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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Oct 2025. 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?
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 Jiarui zhang (15049640955, rad_zhangjiarui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer (time frame: Within 1 month after completion of radiotherapy planning). 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 8 Oct 2025.