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This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT+LDRT+PD-1+Chemotherapy | Experimental | Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | SBRT for metastatic lesions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Defined as the time from randomization to death from any cause. | up to 12 months |
| Objective Response Rate | The percentage of patients with CR and PR assessed according to RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Miao, MD. | Contact | 13631355201 | miaojj@sysucc.org.cn | |
| Chong Zhao, MD. PhD. | Contact | +8687342638 | zhaochong@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD. PhD. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 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 |
|---|---|
| D011878 | Radiotherapy |
| C000656314 | toripalimab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Low-dose Radiotherapy (LDRT) |
| Radiation |
LDRT for metastatic lesions |
|
| Toripalimab | Drug | 6 cycles for combined therapy. Toripalimab maintenance for 1 year. |
|
| Gemcitabine | Drug | 6 cycles for combined therapy. |
|
| Cisplatin | Drug | 6 cycles for combined therapy. |
|
| IMRT | Radiation | IMRT for primary lesion |
|
| up to 12 months |
| Disease Control Rate | The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1. | up to 12 months |
| Adverse Events | All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03 | up to 12 months |
| QoL | Assessed by EQ-5D-5L questionnaire | up to 12 months |
| 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 |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |