Although immunotherapy-based therapies (including targeted-immunotherapy or dual-immunotherapy protocols) have become the first-line standard treatment for advanced hepatocellular carcinoma (HCC), there remains a lack of high-level evidence to guide the selection of second-line therapies following progression in immune checkpoint inhibitors (ICIs). Additionally, direct comparative data are scarce for combination treatment modalities such as "continuation of the original first-line regimen with added agents" or "switching to agents with different mechanisms". To address this clinical need and explore novel second-line treatment strategies for advanced HCC, we plan to conduct an exploratory clinical trial to investigate the efficacy and safety comparison between intensified therapy (plus lenvatinib) and conversion therapy (regorafenib combined with PD-1 inhibitor) for advanced hepatocellular carcinoma after failure of fFirst-line bevacizumab plus sintilimab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Bevacizumab, 15mg/kg, iv drip, q3w; Sintilimab, 200mg/dose, iv drip, q3w; 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), 200mg/dose, iv drip, q3w.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOverall 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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