This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC. 35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended. The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGSuccess rate of conversion to resection
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
Time frame: 3 years
Objective response rate (ORR)
The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)
Time frame: 3 years
Disease control rate (DCR)
The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)
Time frame: 3 years
Progression-free survival (PFS)
The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first
Time frame: 3 years
Time to progression (TTP)
the time interval from first treatment to the first occurrence of disease progression
Time frame: 3 years
Duration of response (DOR)
the time from initial objective response (CR or PR) until PD or death, whichever occurs first
Time frame: 3 years
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause
Time frame: 3 years
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE v5.0.
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Time frame: 3 years