To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
200mg IV d1,Q3W
7.5mg/kg IV d1,Q3W
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGAdverse 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
Time frame: Up to 3 years
Overall survival (OS)
Defined as the time from the date of treatment start to the date of death
Time frame: Up to 3 years
Overall response rate (ORR)
Defined as proportion of patients who have a best response of CR or PR
Time frame: Up to 1 years
Disease control rate (DCR)
Defined as proportion of patients who have a best response of CR, PR or SD
Time frame: Up to 1 years
Quality of Life (QoL)
The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Time frame: Up to 3 years
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