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| Name | Class |
|---|---|
| Beijing Jishuitan Hospital | OTHER |
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To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib and Penpulimab arm | Experimental | Pre-operative IMRT with concurrent and sequential Anlotinib and Penpulimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride | Drug | Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major wound complications | 4-months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late toxicities | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning-Ning Lu | Contact | +868611804268 | Ning-Ning.Lu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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Evaluate quality of life by QOL questionnaires at different time points
| pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up |
| Extremity function | Evaluate quality of life by MSTS forms at different time points | pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up |
| Pathological remission rate | evaluate the tumor remission rate microscopically | 2 weeks after operation |
| Local control | 2-year |
| Overall Survival | 2-year |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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