The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).
This is a prospective, single arm, phase II study to evaluate the efficacy and safety of TACE combined with Sintilimab and Bevacizumab Biosimilar (T-Double Therapy) in patients with HCC (BCLC-C Stage). Subjects who meet the admission criteria will be treated with Sintilimab and Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR) of T-Double Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of T-Double Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of T-Double Therapy for advanced HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
1-4 cycles, intra-arterial infusion: sindilimab 200mg + bevacizumab 7.5mg/kg, q3w; 5-18 cycles: Sintilimab (200mg ivdrip D1 Q3W)+Bevacizumab Biosimilar (15mg/kg ivdrip D1 Q3W)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR) by RECIST 1.1 and mRECIST
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
Time frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to 2 years)
Disease control rate (DCR)
DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST.
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to 2 years)
Duration of response (DOR) by RECIST 1.1 and mRECIST
DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST
Time frame: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to 2 years)
Progression-free survival rate (PFSR) by RECIST 1.1 and mRECIST
PFSR in 6- and 12-months
Time frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years)
Overall survival rate (OSR)
OSR in 6- and 12-months
Time frame: From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to 2 years)
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Progression-free survival time (mPFS)
The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST.
Time frame: From date of first dose of study drug to the date of first documentation of disease progression (up to 2 years)
Median overall survival time (mOS)
OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.
Time frame: From the start date of the Treatment Phase until date of death from any cause (up to 2 years)