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The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.
The study population is patients with advanced osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy treatment. Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. Investigators will evaluate the clinical tumor response to Surufatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Surufatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Surufatinib with the agreement of the sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib | Experimental | Drug: Surufatinib Surufatinib will be given orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib | Drug | Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free rate at 12weeks | at 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | up to 12 months | |
| Objective response rate (ORR) | up to 12 months | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Univerisity | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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| up to 12 months |
| Overall survival (OS) | up to 24 months |