Efficacy and safety of implanted fiducial markers in the treatment of liver malignancies with cyberknife

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072236

Enrollment

Unknown

Registered

2023-06-07

Start date

2022-09-21

Completion date

Unknown

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver malignancies

Interventions

Intervention group:CT guided implantation of fidicual markers + cyberknife therapy

Control group:CT guided implantation of gold markers + cyberknife therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: To be enrolled in this study, subjects must meet all of the following criteria: 1) Age 18-75, gender unlimited; 2) The patient is clinically diagnosed with liver malignancies (including primary liver cancer and liver metastases) and has an indication for stereotactic radiotherapy; 3) Single intrahepatic tumor with tumor diameter =10cm, or no more than 3 intrahepatic tumor lesions with the diameter of all lesions =10cm; 4) Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: Subjects should not participate in the study if: 1) previous epigastric radiotherapy; 2) Severe liver dysfunction (Child-Pugh grade C) or obvious ascites or hepatic encephalopathy; 3) Complicated with active hepatitis or systemic severe infection; 4) Patients with significant decrease in peripheral blood white blood cells or platelets (white blood cells 2; 7) Survival is expected to be less than 3 months; 8) Pregnant or lactating women; 9) Participants who have participated in other clinical trials within the last 3 months; 10) The researcher thinks that participants are not suitable to participate in this researcher due to other reasons.

Design outcomes

Primary

Measure	Time frame
Technical success rate of the marker;	—

Secondary

Measure	Time frame
Focus-tracking success rate;The number of re-implanted markers;Marker offset distance;Researchers' satisfaction with product performance;Objective response rate of disease;	—

Countries

China

Contacts

Public ContactZiqiao Lei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

ziqiao_lei@hust.edu.cn+86 136 0711 5991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026