Metastatic Nasopharyngeal Cancer
Conditions
Keywords
Metastatic Nasopharyngeal Cancer, PD-1, Radiotherapy, Chemotherapy
Brief summary
Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.
Interventions
RADIATIONRadiotherapy
Patients who had complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy receive local radiotherapy 21 days. For those non-CR oligo-metastatic disease or symptomatic lesion, SBRT or conventional RT delivered. Maintenance therapy of immunotherapy for 2 years.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age:18-75 years, male or female. * ECOG 0-2 * Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th) * Complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy * Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. * Adequate organ function. * Patient has given written informed consent.
Exclusion criteria
* Unwilling or unable to provide informed consent * Intolerance to radiotherapy or immunotherapy * Patients who have head and neck radiotherapy history. * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * in other clinical trials within 30 days * Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis; * History of primary immunodeficiency * History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis; * Patients with human immunodeficiency virus (HIV) positive; * Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever \> 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) \< 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis; * not suitable for this study judged by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | 1year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 1year | — |
| Objective response rate (ORR) | 4-8 weeks | — |
| Local-regional free survival (LRFS) | 1 year | — |
| Distant metastasis free survival (DMFS) | 1 year | — |
| Treatment-emergent adverse events | 1 year | Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 5.0 (CTCAE v5.0) |
Countries
China
Contacts
Primary ContactLi Ma, MD
Outcome results
None listed