Clinical trial · Interventional
Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma
A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RT group
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 1year
Secondary outcomes (5)
- measure
- Overall survival (OS)
- timeFrame
- 1year
- measure
- Objective response rate (ORR)
- timeFrame
- 4-8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available