This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
222
Apatinib: 250m, po, QD
Camrelizumab: 200mg, iv, Q3W
TACE if necessary
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. OS will be assessed in the intention-to-treat (ITT) population, which includes all randomized participants.
Time frame: Up to ~4 years
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first. Tumor progression will be assessed according to the RECICL criteria and the mRECIST criteria by investigators and a blinded independent radiology committee (BIRC) in the ITT population.
Time frame: Up to ~2 years
Time to Progression (TTP)
Time to progression is defined as the time from randomization to disease progression that is no longer amenable to transarterial chemoembolization (TACE failure or refractoriness), as assessed according to RECICL and mRECIST criteria in the ITT population.
Time frame: Up to ~2 years
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) after treatment initiation. Tumor response will be assessed according to RECICL and mRECIST criteria by investigators and the BIRC in the ITT population.
Time frame: Up to ~2 years
Duration of Response (DOR)
Duration of response is defined as the time from the first documented CR or PR to disease progression or death from any cause, whichever occurs first. DOR will be assessed according to RECICL and mRECIST criteria in the ITT population.
Time frame: Up to ~2 years
Health-Related Quality of Life (HRQoL)
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Thalidomide:50-75mg, PO, qn;
Capecitabine: 500mg, PO, bid
Compound cantharides capsule: 750mg, PO, tid
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Time frame: Up to ~2 years