A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Stereotactic radiosurgery for liver lesions: with a total dose of 40\~50Gy/3\~5fraction;
Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions
Department of Hepatobiliary Oncology and Radiation Oncology,Tianjin Medical University Cancer Institute & Hospital,Key Laboratory of Cancer Prevention and Therapy,National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer
Tianjin, China
RECRUITINGPFS
Time frame: Until the end of the study, about 2 years
Overall survival rate
Time frame: Until the end of the study, about 2 years
Local control rate
Time frame: Until the end of the study, about 2 years
Intrahepatic control rate
Time frame: Until the end of the study, about 2 years
Extrahepatic control rate
Time frame: Until the end of the study, about 2 years
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