Clinical trial NCT05385926: Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma
Official title: A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Nasopharyngeal Cancer
Keywords: Metastatic Nasopharyngeal Cancer
PD-1
Radiotherapy
Chemotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 1year
measure: Objective response rate (ORR)
timeFrame: 4-8 weeks
measure: Local-regional free survival (LRFS)
timeFrame: 1 year
measure: Distant metastasis free survival (DMFS)
timeFrame: 1 year
measure: Treatment-emergent adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: