Radiotherapy Safety for Liver Malignancies Using Post-Treatment Imaging

NCT07346573 | Completed

• 1 other identifier: CSU-2024-HCCRT001
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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 . 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

Radiation-Induced Liver Injury; Liver Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy

Study Arms (2)

FLR Group

Patients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy

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

Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer

Interventions

Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer OTHER

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.

FLR Group; Non-FLR Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cao peiguo: lead

Study Sites (1)

The Third Xiangya Hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor peiguo Cao, Chief Physician of Radiation Oncology Department, the Third Xiangya Hospital

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 16, 2026
• Study Start: May 1, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)