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Not yet recruiting NCT07211815

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

— Observational Primary Liver Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Liver Cancers. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • Conformity Index Comparison: Body Gamma Knife vs. VMAT for Locally Advanced Primary Liver Cancer [Time frame: Within 1 month after completion of radiotherapy planning]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Chifeng Tumor Hospital — Chifeng

Identifiers

NCT: NCT07211815 · CFSZLYY - FLK - 2025 - 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗