Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Toripalimab and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma

Conditions
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Metastatic Nasopharyngeal Cancer

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT group<br> | Radiation: Radiotherapy<br>* Patients who had complete response or partial response after at least 3 cycles (no more than 6 cycles) of Gemcitabine plus cisplatin combined with Toripalimab receive local radiotherapy 21 days. For those non-CR oligo-metastatic disease or symptomatic lesion, SBRT or conventional RT delivered. Maintenance therapy of Toripalimab for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 1year | 
| Objective response rate (ORR) |  | 4-8 weeks | 
| Local-regional free survival (LRFS) |  | 1 year | 
| Distant metastasis free survival (DMFS) |  | 1 year | 
| Treatment-emergent adverse events | Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 5.0 (CTCAE v5.0) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1, Chemotherapy, Metastatic Nasopharyngeal Cancer, Radiotherapy