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The main purpose of this study is to see how well the experimental drug camrelizumab(SHR-1210) works in people with oligometastatic NPC who have already had locally radiotherapy for their disease. All patients will receive 200 mg of camrelizumab intravenously on Day 1 of each 21-day cycle. Patients will receive the study drug for up to 18 cycles.
Each subject included in this project must sign an informed consent form. Within 4-6 weeks after completing radiotherapy and chemotherapy for oligometastatic lesions, subjects will receive camrelizumab 200 mg fixed-dose treatment every three-week (Q3W).
If there is no confirmed disease progression, unacceptable adverse events or concurrent diseases (need further treatment ), the researcher decides to withdraw from the subject, the subject withdraws from treatment, the subject is pregnant, and other reasons that do not meet the requirements of the trial treatment or procedure, The treatment with camrelizumab will last at least 12 months. Patients with no signs of disease progression can be treated with another 6 to 12 months by the decision of researcher.
After treatment, each subject will be followed up. Subjects should be monitored for adverse events for at least 30 days, and serious adverse events will be over 90 days. Subjects will be followed up 5 years from the last treatment or until one of the following events: ① disease progression; ② receive other treatments of cancer; ③ withdraw research consent; ④ loss of follow-up; ⑤ death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab | Experimental | Camrelizumab 200mg every 21 days for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg every 21 days (3 weeks) for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Time to progression or death from initiation of Camrelizumab | 3 years |
| Drug toxicity and tolerability | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Life Quality | Evaluate patient quality of life by EORTC QLQ-C30 scale(Scores range from 0 to 100,a high functional scale score represents a high/healthy level of functioning, while a high symptom scale score indicates a high level of symptomatology or problems) | 3 years |
| Overall Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Potential predictive biomarkers associated with therapeutic efficacy and prognosis | PD-L1 expression;Tumor Mutational Burden(TMB);Tumor related gene changes; plasma EBV DNA copies ; cytokine; etc | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Guan, Ph.D. | Contact | +86-13632102247 | 51643930@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Guan, Ph.D. | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern medical university | Recruiting | Guangzhou | Guangdong | 510515 | 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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Time to death from initiation of Camrelizumab |
| 3 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 |