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Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab + VEX metronomic chemotherapy + radiotherapy | Experimental |
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| Adebrelimab + VEX metronomic chemotherapy | Active Comparator |
Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab + VEX metronomic chemotherapy + radiotherapy | Drug | 1、Adebrelimab: 1200mg on day 1, every 3 weeks; 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | According to RECIST 1.1 criteria:Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression). | 24 months |
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Subjects are eligible to be included in the study only if all of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Ma 马 | Contact | 010-87788120 | 010-87788120 | drmafei@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Adebrelimab + VEX metronomic chemotherapy | Drug | 1、Adebrelimab: 1200mg on day 1, every 3 weeks; 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W |
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| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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