Status:
RECRUITING
Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Metastatic Nasopharyngeal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 out...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05385926
Start Date
May 5 2022
End Date
April 30 2024
Last Update
February 5 2024
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Shenzhen, China