Status:
ACTIVE_NOT_RECRUITING
Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC
Lead Sponsor:
Jonggi Choi
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related mortality and the sixth most prevalent cancer in the world. Standard treatments for early-stage HCCs include resection, live...
Detailed Description
A total of 178 subjects are randomly assigned to one of two treatment groups (89 patients in the body stereotactic radiotherapy group and 89 patients in the radiofrequency ablation group). If the assi...
Eligibility Criteria
Inclusion
- patient over the age of 18
- primary or recurrent HCC that is not suitable for surgery
- HCCs with a longest diameter of ≤3cm and ≤2 lesions
- no evidence of intrahepatic or extrahepatic residual disease except for target lesions
- Child-Pugh class A or B hepatic function
- no macroscopic vascular invasion or extrahepatic metastasis
- written informed consent
Exclusion
- Eastern Cooperative Oncology Group performance status score 3 or 4
- uncontrolled ascites, variceal bleeding, or hepatic encephalopathy
- previous history of liver transplantation
- an active gastric or duodenal ulcer within 3 months before screening
- pregnant woman
- uncontrolled other malignancies except for HCC within 2 years before screening
- platelet count \<50,000/µl
- Patients who are judged by the researcher to be difficult to conduct clinical research
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT05433701
Start Date
August 29 2022
End Date
December 31 2026
Last Update
August 18 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505