The purpose of this study is to evaluate the efficacy and safety of PD-1 Inhibitor (QL1604) plus chemotherapy in patients with Stage IV, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.
The study will be conducted in 2 parts.The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Sun Yat-Sen University Cancer Center
Guangzhou, Guangzhou, China
Percentage of patients with adverse events
The incidence and severity of adverse events (AE),serious adverse events (SAE) and treatment-emergent adverse events (TEAEs) according to CTCAE V5.0
Time frame: Up to 90 days from last dose
Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST
Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST
Time frame: approximately 2 years
Progression-free survival (PFS) as assessed by investigator based on RECIST v1.1 and iRECIST
Progression-free survival (PFS) is defined as time from the date of randomization to the date of first documentation of disease progression or death due to any cause(whichever occurs earlier)
Time frame: approximately 2 years
Overall survival(OS)
Overall survival(OS) is defined as the time from randomization to death due to any cause
Time frame: approximately 2 years
Duration of response(DOR)
Duration of response(DOR) as assessed by investigator based on RECIST v1.1 and iRECIST
Time frame: approximately 2 years
Time to progress (TTP)
Time to progress (TTP) as assessed by investigator based on RECIST v1.1 and iRECIST
Time frame: approximately 2 years
AUC of QL1604
Area under curve from zero to infinity
Time frame: approximately 1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax of QL1604
Peak concentration
Time frame: approximately 1 years
Cmin of QL1604
The trough value at steady state
Time frame: approximately 1 years
Tmax of QL1604
Time to Cmax
Time frame: approximately 1 years
T1/2 of QL1604
Half life
Time frame: approximately 1 years
Vss of QL1604
Steady-state apparent volume of distribution based on plasma concentration
Time frame: approximately 1 years
CLT(total body clearance) of QL1604
Total body clearance
Time frame: approximately 1 years
Immunogenicity
The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab)
Time frame: approximately 1 years