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To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penplimab Injection | Drug | Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause. | Baseline up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR) | Baseline up to 2 years |
| Disease Control Rate (DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaozhong Chen, Doctor | Contact | 0571-88128202 | chenxz@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| Antitinib Hydrochloride Capsules | Drug | 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. |
|
| Gemcitabine | Drug | Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles. |
|
| Baseline up to 2 years |
| Overall survival (OS) | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up | Baseline up to 2 years |
| Time to Response (TTR) | TTR defined as the time from randomization to the first recorded CR or PR | Baseline up to 2 years |
| Duration of Response (DOR) | DOR defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. | Baseline up to 2 years |
| PD-L1 expression | Evaluating the correlation between PD-L1 expression and efficacy in tumor tissue samples. | Tumor tissue samples must be provided to the research center prior to initial administration |
| Blood EBV level | Evaluate the correlation between the copy number of EBV DNA in the blood of subjects and their efficacy. | Baseline up to 2 years |
| Evaluate the health-related quality of life (HRQoL) of subjects | Evaluate the health-related quality of life (HRQoL) of subjects using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scale。The minimum values is 1,the maximum values is 4,and whether higher scores mean a worse outcome. | Baseline up to 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |