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It is difficult to screening subject
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This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| famitinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | po |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate per RECIST 1.1 | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Response | At pre-defined intervals from initial dose up to 24 months |
| DCR | Disease Control Rate | At pre-defined intervals from initial dose up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C584390 | famitinib |
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| PFS | Progression-Free-Survival | At pre-defined intervals from initial dose up to 24 months |
| OS | Overall survival | At pre-defined intervals from initial dose up to 24 months |
| Adverse events (AE) and serious adverse event (SAE) | Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug | At pre-defined intervals from initial dose up to 24 months |
| Plasma concentrations of famitinib and its N-desethyl metabolite | At pre-defined intervals from initial dose up to 24 months |
| D009369 | Neoplasms |