There is no definitive evidence regarding the therapeutic efficacy of PD-1 inhibitors combined with tyrosine kinase inhibitors (TKIs) after disease progression following first-line treatment with bevacizumab plus sintilimab for unresectable hepatocellular carcinoma (HCC). There is insufficient evidence to support which TKI should be combined with PD-1 inhibitors as the optimal second-line treatment option after first-line therapy failure. Data on the application of lenvatinib as a second-line treatment are limited, whereas the efficacy and safety of regorafenib combined with PD-1 inhibitors have been preliminarily validated \[9\]. Therefore, this study aims to compare the efficacy and safety of PD-1 inhibitors combined with either lenvatinib or regorafenib after disease progression following first-line bevacizumab plus sintilimab treatment for unresectable HCC, providing evidence-based guidance for the selection of second-line treatment regimens in clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight \>60 kg, 12 mg/d, po, qd.
Regorafenib, 160mg/d, po, qd.
PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab, Nivolumab), 200mg/dose, iv drip, q3w.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall Survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 6 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
Time frame: 6 months
Objective Response Rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Time frame: 6 months
Adverse Events
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Time frame: 30 days
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