This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGGrade≥3 drug-related adverse events (TRAEs).
Time frame: Up to 3 years.
Grade≥3 drug-related serious adverse events (TRAEs).
Time frame: Up to 3 years.
Objective response rate (ORR).
Time frame: Up to 3 years.
Duration of response (DOR).
Time frame: Up to 3 years.
Disease control rate (DCR).
Time frame: Up to 3 years.
Progression-free survival (PFS).
Time frame: Up to 3 years.
Overall survival (OS).
Time frame: Up to 3 years.
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SHR-8068 injection.
Cisplatin injection.
Carboplatin injection.