This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10mg/kg administered intravenously (IV)
1 g/m2, administered as an IV infusion within 30 minutes
80 mg/m2, administered as an IV infusion over 4 hours
Objective response rate(ORR)
ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
Incidence and severity of adverse events(AEs)
Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
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