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Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling
Phase 2

Conditions

Metastatic Nasopharyngeal Cancer

Treatments

Radiation: Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05385926
JS2022-35

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

RT group
Experimental group
Treatment:
Radiation: Radiotherapy

Trial contacts and locations

1

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Central trial contact

Li Ma, MD

Data sourced from clinicaltrials.gov

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