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The primary objective of this clinical trial is to evaluate the efficacy and safety of spatially fractionated radiotherapy combined with the PraG strategy in the treatment of soft tissue sarcoma (STS). The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFRT + PraG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | week 4 |
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Inclusion Criteria:
Age: 18-75 years old, both genders are eligible.
Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:
Disease Stage:
Prior Therapy:
Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.
Performance Status: ECOG performance status score of 0-2.
Life Expectancy: ≥3 months.
Organ Function:
Informed Consent: The patient or their legal representative has signed the informed consent form.
Exclusion Criteria:
Special Types of Sarcoma:
Prior Treatment History:
Concurrent Diseases:
Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.
Pregnancy and Lactation: Women who are pregnant or breastfeeding.
Allergy History: Known allergies to the drugs or their components involved in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Lv | Contact | 86 + 13481095127 | 87800197@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | 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 |
|---|---|
| C000656314 | toripalimab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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