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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2102 Group | Experimental | Participants receive SHR-A2102 for injection. |
|
| The investigator's choice of chemotherapy Group | Active Comparator | Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 for Injection | Drug | SHR-A2102 for injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. | Up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Assessed by the investigator according to RECIST 1.1 criteria. | Up to 3 years. |
| Objective Response Rate (ORR) | Assessed by the investigator according to RECIST 1.1 criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifei Lin | Contact | +86-0518-82342973 | zhifei.lin.zl3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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An open-label, randomized, controlled, multicenter, phase III Study.
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| Pemetrexed Disodium for Injection |
| Drug |
Pemetrexed Disodium for injection. |
|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine Hydrochloride for injection. |
|
| Topotecan Hydrochloride for Injection | Drug | Topotecan Hydrochloride for injection. |
|
| Paclitaxel for Injection (Albumin bound) | Drug | Paclitaxel for injection (Albumin bound). |
|
| Up to 3 years. |
| Duration of response (DoR) | Assessed by the investigator according to RECIST 1.1 criteria. | Up to 3 years. |
| Disease control rate (DCR) | Assessed by the investigator according to RECIST 1.1 criteria. | Up to 3 years. |
| Adverse Events (AEs) | Including incidence and grade, judged according to NCI-CTCAE V5.0 standards. | Up to 3 years. |
| Serious Adverse Events (AEs) | Including incidence and grade, judged according to NCI-CTCAE V5.0 standards. | Up to 3 years. |
| Plasma concentrations of SHR-A2102 | Pharmacokinetics (PK) traits of SHR-A2102. | Up to 3 years. |
| Plasma concentrations of SHR-A2102 metabolites | Pharmacokinetics (PK) traits of SHR-A2102. | Up to 3 years. |
| Incidence of Anti-Drug Antibody (ADA) of SHR-A2102 | Up to 3 years. |
| Incidence of Neutralizing Antibodies (Nab) of SHR-A2102 | Up to 3 years. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D019772 | Topotecan |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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