A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)
Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGTTP assessed by independent review committee(IRC)
Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).
Time frame: up to 24 months after enrollment or study close
TTP assessed by investigators
Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression, assessed by investigators per mRECIST.
Time frame: An expected average of 8 months
PFS
Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.
Time frame: An expected average of 8 months
ORR
Defined as the proportion of patients with a documented CR or PR, assessed by IRC and investigators, respectively, per mRECIST.
Time frame: An expected average of 8 months
DCR
Defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by IRC and investigators, respectively, per mRECIST.
Time frame: An expected average of 8 months
DOR
Defined as the time from the first confirmation of objective remission (CR or PR) to the first recording of disease progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST.
Time frame: An expected average of 8 months
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OS
Defined as the time from the treatment initiation to the date of death due to any cause.
Time frame: An expected average of 24 months
Safety
NCI-CTCAE v5.0.
Time frame: up to 24 months after enrollment or study close