The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day.
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGObjective Response Rate (ORR)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 12 months
Progression-free survival(PFS)
Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 12 months
Time to objective response(TTR)
Time to objective response(TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 12 months
Duration of Response (DoR)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 12 months
6-month survival rate
6-month survival rate
Time frame: Up to approximately 12 months
9-month survival rate
9-month survival rate
Time frame: Up to approximately 12 months
12-month survival rate
12-month survival rate
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Time frame: Up to approximately 12 months
Overall survival(OS)
Time frame: Up to approximately 24 months
Safety as measured by the rate of AEs, SAEs and laboratory abnormalities
Safety as measured by the rate of AEs, SAEs and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 )
Time frame: From the first assignment of informed consent form up to 90 days after the last dose