The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
SHR-A2102 for injection.
Pemetrexed Disodium for injection.
Gemcitabine Hydrochloride for injection.
Topotecan Hydrochloride for injection.
Paclitaxel for injection (Albumin bound).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOverall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Time frame: Up to 3 years.
Progression free survival (PFS)
Assessed by the investigator according to RECIST 1.1 criteria.
Time frame: Up to 3 years.
Objective Response Rate (ORR)
Assessed by the investigator according to RECIST 1.1 criteria.
Time frame: Up to 3 years.
Duration of response (DoR)
Assessed by the investigator according to RECIST 1.1 criteria.
Time frame: Up to 3 years.
Disease control rate (DCR)
Assessed by the investigator according to RECIST 1.1 criteria.
Time frame: Up to 3 years.
Adverse Events (AEs)
Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.
Time frame: Up to 3 years.
Serious Adverse Events (AEs)
Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.
Time frame: Up to 3 years.
Plasma concentrations of SHR-A2102
Pharmacokinetics (PK) traits of SHR-A2102.
Time frame: Up to 3 years.
Plasma concentrations of SHR-A2102 metabolites
Pharmacokinetics (PK) traits of SHR-A2102.
Time frame: Up to 3 years.
Incidence of Anti-Drug Antibody (ADA) of SHR-A2102
Time frame: Up to 3 years.
Incidence of Neutralizing Antibodies (Nab) of SHR-A2102
Time frame: Up to 3 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.