NCT06766643

Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites

Detailed description

This study is a prospective, randomized, controlled Phase II clinical trial aimed at recruiting patients with primary liver cancer who are deemed inoperable after surgical evaluation, with tumor lesions located near major blood vessels, the diaphragm, the liver capsule, or the porta hepatis. The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy and radiofrequency ablation as treatment options for such patients. It must be determined by the investigator whether stereotactic radiotherapy or radiofrequency ablation is the preferred treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to one of the following treatment groups: stereotactic radiotherapy or radiofrequency ablation. The study is expected to enroll 65 patients in each group.

Conditions

• Primary Liver Cancer

Interventions

Type	Name	Description
PROCEDURE	Stereotactic Body Radiation Therapy (SBRT)	Stereotactic radiosurgery for liver lesions: with a total dose of 40\~50Gy/3\~5fraction;
PROCEDURE	Radiofrequency ablation therapy	Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-01-01
• Completion: 2026-12-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China