This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SHR-2524 injection.
Bevacizumab injection.
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGTrough serum concentrations (C21d)
Pharmacokinetics (PK) parameters.
Time frame: 0 - 21 days.
Area under curve from Day 0 to Day 21 (AUC0-21d)
Pharmacokinetics (PK) parameters.
Time frame: 0 - 12 days.
Area under curve up to 21 weeks (AUC0-21weeks)
Pharmacokinetics (PK) parameters.
Time frame: 0 - 12 weeks.
Maximum blood concentration (Cmax)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
Time to peak concentration (Tmax)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
Elimination half-life (t1/2)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
Rate of clearance (CL/F)
Pharmacokinetics (PK) parameters.
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Time frame: About 9 months.
Geometric mean of the apparent volume of distribution of the population (Vz/F)
Pharmacokinetics (PK) parameters.
Time frame: About 9 months.
The number and percentage of anti-drug antibody (ADA) positive participants
Immunogenicity parameter.
Time frame: About 9 months.
Adverse events (AEs)
Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of adverse events (AEs).
Time frame: About 9 months.
Serious adverse events (SAEs)
Safety parameters: The type, incidence, grade (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v6.0), severity and correlation with Investigational Medicinal Products (IMP) of serious adverse events (SAEs).
Time frame: About 9 months.
Investigator - assessed objective response rate (ORR) based on RECIST v1.1
Efficacy parameters.
Time frame: About 9 months.
Investigator - assessed duration of response (DoR) based on RECIST v1.1
Efficacy parameters.
Time frame: About 9 months.
Investigator - assessed disease control rate (DCR) based on RECIST v1.1
Efficacy parameters.
Time frame: About 9 months.
Investigator - assessed progression-free survival (PFS) based on RECIST v1.1
Efficacy parameters.
Time frame: About 9 months.
Investigator - assessed overall survival (OS) based on RECIST v1.1
Efficacy parameters.
Time frame: About 9 months.