Efficacy of Chemoradiotherapy and Immunotherapy, Multi-omics Technique, Nasopharyngeal Carcinoma, Recurrent and Metastatic Nasopharyngeal Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGcisplatin-based chemoradiotherapy combined with immunotherapy
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
Sponsors
Sun Yat-sen University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent or metastatic nasopharyngeal carcinoma patients * All genders，range from 18～70 years old * ECOG score 0 \~ 1 * Inform consent form
Exclusion criteria
* Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Drug or alcohol addition; * Do not have full capacity for civil acts; * Mental disorder; * Pregnancy or lactation; * Severe complication, eg, uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | 3 years | To investigate the multi-omics technique to predict the 3-year failure-free survival of chemoradiotherapy combined with immunotherapy for r/m NPC patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA | through study completion, an average of 6 months | To show the changes of ctDNA during the treatment among these patients |
| Tumor mutation load at DNA level | through study completion, an average of 6 months | To show the changes of tumor mutation load at DNA level during the treatment among these patients |
| RNA expression | through study completion, an average of 6 months | To show the changes of RNA expression during the treatment among these patients |
Countries
China
Contacts
CONTACTJingjing Miao, M.D
PRINCIPAL_INVESTIGATORChong Zhao, M.D
Sun Yat-Sen University Cancer Center
Outcome results
None listed