This is a Phase Ib study to evaluate the safety and efficacy of sintilimab combined with bevacizumab biosimilar in patients with potentially resectable intermediate hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sintilimab: 200mg IV Q3W D1
Bevacizumab biosimilar: 15mg/kg, IV, Q3W, D1
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss,PHLF assessed by ISGLS(2012),Postoperative complications evaluated by modified Clavien-Dindo system
Time frame: Up to 2 years
Events Free Survival (EFS) Assessed by RECIST1.1
Defined as the time from enrollment to disease progression, recurrence or death (whichever occurs first)
Time frame: Up to 2 years
resection rate (R0 resection rate)
Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate)
Time frame: Up to 2 years
Pathological response rate
Defined as the proportion of patients who had pathological response.
Time frame: Up to 2 years
Objective response rate (ORR) assessed by RECIST1.1
Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Time frame: Up to 2 years
Recurrence-free survival (RFS) of patients who accepted surgery
Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first, assessed up to 2 years post-treatment
Time frame: Up to 2 years
Progression free survival (PFS) assessed by RECIST1.1 of patients who didn't accept surgery
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Defined as the time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: Up to 2 years
Overall survival (OS) of the patients who accepted surgery
Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive.
Time frame: Up to 2 years
Overall survival (OS) of the patients who didn't accepted surgery
Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive.
Time frame: Up to 2 years
Overall survival (OS)
Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive
Time frame: Up to 2 years