Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    34
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 7 June 2022

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.

Details
Condition Metastatic Nasopharyngeal Cancer
Treatment Radiotherapy
Clinical Study IdentifierNCT05385926
SponsorChinese Academy of Medical Sciences
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

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 Gemcitabine plus cisplatin combined with Toripalimab
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
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