Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy | Experimental | Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma,once every 2 weeks, 10 cycles in total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | PD-1 Immune Checkpoint Inhibitor Combined With IMRT,used at 2 weeks before radiotherapy, once every 2 weeks, 10 cycles in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The severity of adverse events will be determined by the investigator based on CTCAE v 5.0 | Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Patients in clinical trials were randomized to the time of death from any cause | 2 years |
| progression-free survival (PFS) | The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqun Xiang, Dr | Contact | +86-18666096623 | xiangyq@sysucc.org.cn | |
| Weixiong Xia, Dr | Contact | +86-18520415699 | xiawx@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanqun Xiang, Dr | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanqun Xiang | Recruiting | Guangzhou | Guangdong | 510000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intensity modulated radiotherapy | Procedure | Intensity modulated radiotherapy |
|
| 2 years |
| Distant metastasis-free survival(DMFS) | Patients in clinical trials were randomized to the time of distant metastasis | 2 years |
| Response rate (based on RECIST ver1.1) | According to the remission assessment criteria of solid tumors,divided into CR, PR, SD, PD. CR(complete response) All target lesions disappeared and no new lesions appeared PR ( partial response) reduction of the sum of the largest diameters of target lesions by ≥30%) SD(stable disease)the sum of the largest diameters of target lesions does not shrink to PR, or increases to PD PD(progressive disease) The sum of the largest diameters of target lesions increases by at least 20%, or new lesions appear | Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided