The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Camrelizumab: 200mg, iv, Q3W
TACE if necessary
Apatinib: 250m, po, QD
Zhongda Hospital
Nanjing, Jiangsu, China
Progression-free survival (PFS) by investigator
PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
Time frame: Up to ~2 years
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to ~4 years
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: Up to ~2 years
Time to untreatable (unTACEable) progression (TTUP) by investigator
TTUP is defined as the time from randomization to Child-Pugh grade C, intrahepatic tumor progression (\>50% increase vs baseline), MVI or EHS (diameter\>10 mm), and met the JSH criteria for TACE failure/refractoriness.
Time frame: Up to ~2 years
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