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To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.
To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 immune checkpoint inhibitor combined with bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab | Drug | combined |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Patients in clinical trials were randomized to the time of death from any cause | 2 years |
| progression-free survival (PFS) | 36/5000 The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanqun Xiang, Dr. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanqun Xiang | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37593221 | Derived | Lu N, Jiang YF, Xia WX, Huang Y, Xie CM, Xu C, Ye YF, Liu GY, Bei WX, Ke LR, Li WZ, Zhang C, Wang X, Liu Q, Chen X, Chen ZX, Xie C, Liang H, Xiang YQ. Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. EClinicalMedicine. 2023 Aug 4;62:102136. doi: 10.1016/j.eclinm.2023.102136. eCollection 2023 Aug. |
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| 2 years |
| duration of response (DOR) | The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause. | 2 years |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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