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Not yet recruitingNCT07211815Updated Oct 8, 2025

Dosimetric Differences and Clinical Significance Analysis Between Body Gamma Knife and VMAT Radiotherapy for Primary Liver Cance

An observational study in Primary Liver Cancers, sponsored by Chifeng Tumor Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-08.

Sponsored by Chifeng Tumor Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Primary Liver Cancers
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In context

Lead sponsor

Chifeng Tumor Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

Secondary outcomes

  1. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

  2. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

  3. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

  4. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

  5. 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.

    Time frame: Within 1 month after completion of radiotherapy planning

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Study locations

1 site
  • Chifeng Tumor Hospital
    Chifeng, Inner Mongolia 024000, China
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07211815
Lead sponsor
Chifeng Tumor Hospital
Responsible party
Sponsor
First posted
Oct 8, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Oct 8, 2025

Study contacts

Jiarui zhang
Contact
rad_zhangjiarui@163.com
15049640955

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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