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This study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. The feasibility of continuously oral administration combined with camrelizumab in reducing the incidence of adverse events (especially grade ≥3 adverse events) in patients by dose reduction while maintaining comparable efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Famitinib 20 mg QD PO + Camrelizumab 200 mg IV Q3W |
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| Arm 2 | Experimental | Famitinib 15 mg QD PO + Camrelizumab 200 mg IV Q3W |
|
| Arm 3 | Experimental | Famitinib 10 mg QD PO + Camrelizumab 200 mg IV Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib + Camrelizumab | Drug | Famitinib + Camrelizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first | up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate per RECIST v1.1 by investigator | defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaiwu Lu | Contact | +86 020-81332199 | luhuaiwu@mail.sysu.edu.cn |
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| up to approximately 2 years |
| ID | Term |
|---|---|
| C584390 | famitinib |
| C000631724 | camrelizumab |
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