The purpose of this study is to explore the efficacy and safety of SHR-1210 in combination with apatinib in treating patients with metastatic, persistent, or recurrent cervical cancer.
SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) selectively inhibits Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2). Patients with metastatic, persistent, or recurrent cervical cancer who failed to first-line chemotherapy +/- bevacizumab will received SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks and apatinib 250mg orally once daily. The efficacy and safety will be observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
The First affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 12 months
Progression-free Survival (PFS)
Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause
Time frame: Up to approximately 24 months
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time frame: Up to approximately 24 months
6-month PFS rate
The rate of 6-month PFS
Time frame: From date of enrollment up to 6 months
9-month OS rate
The rate of 9-month OS
Time frame: From date of enrollment up to 9 months
Duration of Response (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
Time frame: Up to approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
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Time frame: Up to approximately 24 months
Incidence of Adverse Events (AEs) in the treatment of SHR1210 in combination with apatinib
Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Time frame: Up to approximately 24 months