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The observational clinical study will recruit 50 recurrent and/or metastatic nasopharyngeal carcinoma (r/mNPC) patients, to investigate the prediction values of multi-omics technique for the efficacy of chemoradiotherapy combined with immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiotherapy combined with immunotherapy | Patients treated with chemoradiotherapy combined with immunotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin-based chemoradiotherapy combined with immunotherapy | Drug | Chemotherapy:cisplatin-based chemotherapy GP/TP/PF/TPF Choice of chemotherapy regimen is decided by patient's doctor in charge. Radiation: Intensity Modulated Radiation Therapy All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225). Immunotherapy:PD-1 blocking antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | To investigate the multi-omics technique to predict the 3-year failure-free survival of chemoradiotherapy combined with immunotherapy for r/m NPC patients | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA | To show the changes of ctDNA during the treatment among these patients | through study completion, an average of 6 months |
| Tumor mutation load at DNA level | To show the changes of tumor mutation load at DNA level during the treatment among these patients |
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Inclusion Criteria:
Exclusion Criteria:
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Recurrent or metastatic nasopharyngeal carcinoma patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Miao, M.D | Contact | 86-13631355201 | miaojingjing90@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, M.D | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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| through study completion, an average of 6 months |
| RNA expression | To show the changes of RNA expression during the treatment among these patients | through study completion, an average of 6 months |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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