Radiotherapy Safety for Liver Malignancies Using Post-Treatment Imaging

NCT ID: NCT07346573

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2025-03-01

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

Liver Neoplasms; Radiation-Induced Liver Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

FLR Group

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

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

Intervention Type: 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.

Non-FLR Group

Patients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cao peiguo

OTHER

Sponsor Role: lead

Responsible Party

Cao peiguo

Professor peiguo Cao, Chief Physician of Radiation Oncology Department, the Third Xiangya Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Third Xiangya Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

CSU-2024-HCCRT001

Identifier Type: -

Identifier Source: org_study_id