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This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab combined with famitinib malate | Experimental |
| |
| platinum-based chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumabï¼› famitinib malate | Drug | Camrelizumab intravenously ; Famitinib Orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria | up to 2 years | |
| Overall survival (OS) | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria | up to 2 years | |
| Objective response rate (ORR) assessed based on RECIST V1.1 criteria | up to 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
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| platinum-based chemotherapy | Drug | Physician's choice chemotherapy |
|
| Disease control rate (DCR) assessed based on RECIST V1.1 criteria |
| up to 2 years |
| Duration of response (DOR) assessed based on RECIST V1.1 criteria | up to 2 years |
| Time to response (TTR) assessed based on RECIST V1.1 criteria | up to 2 years |
| Time to treatment failure (TTF) | up to 2 years |
| Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression | up to 2 years |
| 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 |