This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
This is a single-center, prospective study to evaluate the efficacy and safety of sintilimab, bevacizumab plus SIRT (Sin-Bev-SIRT) in patient with unresectable HCC. 23 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive sintilimab (200mg I.V. Q3W) and bevacizumab (7.5mg/kg I.V. Q3W) at 3-7 days after SIRT. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg/kg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGProgression free survival (PFS) according to mRECIST
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 3 years
Progression free survival (PFS) according to RECIST 1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 3 years
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1
Time frame: 3 years
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
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.
Time frame: 3 years
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