Transcatheter arterial chemoembolization (TACE) is recommended as the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC) (i.e., BCLC stage B). However, these patients is heterogeneous in terms of liver functional, tumor size and tumor number, and not all patients with mid-stage HCC will benefit from TACE. The ORIENT-32 trial confirmed the efficacy of sintilimab in combination with bevacizumab for unresectable hepatocellular carcinoma. No study has yet explored whether this regimen is appropriate for patients with BCLC stage B. The purpose of this study is to explore whether bevacizumab in combination with sintilimab is superior to conventional TACE therapy in patients with HCC with beyond-Up-to-seven criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Bevacizumab combined with sintilimab, sindilizumab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
Transcatheter arterial chemoembolization, patients were treated with cTACE, and the efficacy was assessed by repeat CT/MRI 1 month after the initial treatment, and if the tumor still had arterial phase enhancement, TACE treatment could be supplemented until treatment failure and withdrawal of consent.
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGprogression free survival,PFS
Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2
Time frame: 24 months
overall survival, OS
Defined as the time from the start of randomization to death from any cause.
Time frame: 24 months
post-progression survival,PPS
Defined as overall survival minus progression-free survival time
Time frame: 24 months
Time to failure of treatment strategy
Time from randomization to death or need for further treatment options
Time frame: 24 months
Duration of Response, DOR
Time from initial response to disease progression or death in patients identified as CR or PR according to mRECIST and RECIST 1.1 criteria
Time frame: 24 months
objective response rate,ORR
Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)
Time frame: 24 months
conversion rate to resection
Rate of patients whose tumors regressed and underwent surgical resection
Time frame: 24 months
Patient-reported outcomes, PRO
Change from baseline in overall health, quality of life, physical, role, emotional, and social functioning using the IL42-EORTCQLQ-C30 scale
Time frame: 24 months
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