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Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalpiciclib plus Camrelizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib Isetionate Tablets, Camrelizumab | Drug | Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Median progression-free survival (PFS) | Progression-free survival is defined as the time to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened. | 1 year |
| Median overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD, PhD | Contact | 86-20-8734-3361 | chmingy@mail.sysu.edu.cn | |
| Rui You, PhD | Contact | 86-13580439820 | yourui@sysucc.org.cn |
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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 |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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Overall survival is defined as the time to the date of death of any cause, censored on the last date of known survival if no death has happened. |
| 3 years |
| Duration of response (DoR) | Defined as the time from first documentation of objective response to radiological disease progression | 1 year |
| Disease control rate (DCR) | Disease control rate is the rate of patients achieving complete response, partial response or stable disease | 1 year |
| Incidence of adverse events | NCI-CTCAE 5.0 standard is adopted. | 1 year |
| 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 |