Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

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