This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
SHR-A1811 for injection.
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGShandong University Qilu Hospital
Jinan, Shandong, China
RECRUITINGObjective response rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Overall survival (OS) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Overall survival (OS) assessed by investigators
Time frame: Up to 2 years.
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Progression free survival (PFS) assessed by investigators
Time frame: Up to 2 years.
Duration of response (DoR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Duration of response (DoR) assessed by investigators
Time frame: Up to 2 years.
Disease control rate (DCR) assessed by Independent Review Committee (IRC)
Time frame: Up to 2 years.
Disease control rate (DCR) assessed by investigators
Time frame: Up to 2 years.
Objective response rate (ORR) assessed by investigators
Time frame: Up to 2 years.
Adverse events (AEs)
Time frame: Up to 2 years.
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Serious adverse events (SAEs)
Time frame: Up to 2 years.