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This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab combined with famitinib malate and chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Intravenous (IV) on Day 1 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. | up to 2 years |
| Duration of response (DOR) | Duration of Response per RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Tang | Contact | 0731-89762071 | tangjie@hnca.org.cn |
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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 |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Famitinib Malate | Drug | Famitinib po qd |
|
| Chemotherapy | Drug | Paclitaxel + cisplatin or carboplatin |
|
| Up to 2 years |
| Time to response (TTR) | TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1. | up to 2 years |
| Progression-free survival (PFS) | PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death. | Up to 2 years |
| Overall Survival (OS) | OS was defined as the time from the date of first dose until death due to any cause. | Up to 2 years |
| Safety | Incidence, type and severity of adverse events | 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 |