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This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAP | Experimental |
| |
| GPP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg, D1, Q3W, iv drip. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | the time from treatment initiation to disease progression or death from any cause. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the survival time until death from any cause | 2 years |
| Objective response rate | the proportion of patients with complete response (CR) or partial response (PR) according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine |
| Drug |
1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles. |
|
| Cisplatin | Drug | 80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles. |
|
| Apatinib | Drug | 250mg, PO, QD |
|
| 2 years |
| Disease control rate | the proportion of patients who achieved CR, PR, or stable disease | 2 years |
| Duration of response | the time from the first evidence of response to disease progression or death | 2 years |
| Safety evaluation | incidence of adverse events | 2 years |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |