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.
Participate in the study voluntarily, sign the informed consent form.
Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
Provide primary or metastatic tumor samples.
At least one measurable lesion (RECIST version 1.1).
With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
With a history of or concurrent other malignant tumor(s).
Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
Parallel
SHR-A2102 for Injection
DrugSHR-A2102 for injection.
Pemetrexed Disodium for Injection
DrugPemetrexed Disodium for injection.
Gemcitabine Hydrochloride for Injection
DrugGemcitabine Hydrochloride for injection.
Topotecan Hydrochloride for Injection
DrugTopotecan Hydrochloride for injection.
Paclitaxel for Injection (Albumin bound)
DrugPaclitaxel for injection (Albumin bound).
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Progression free survival (PFS)
Assessed by the investigator according to RECIST 1.1 criteria.
Objective Response Rate (ORR)
Assessed by the investigator according to RECIST 1.1 criteria.
Duration of response (DoR)
Assessed by the investigator according to RECIST 1.1 criteria.
Disease control rate (DCR)
Assessed by the investigator according to RECIST 1.1 criteria.
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