Combining radiotherapy with immunotherapy and chemotherapy for metastatic nasopharyngeal cancer
A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma
This study is testing if combining radiation therapy with immunotherapy and chemotherapy can help people with metastatic nasopharyngeal cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shenzhen) |
| Trial ID | NCT05385926 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of combining radiotherapy with first-line immunochemotherapy in patients diagnosed with metastatic nasopharyngeal carcinoma. Participants will receive chemotherapy and PD-1 immunotherapy, followed by radiotherapy to assess improvements in progression-free survival. The study aims to determine if this combination can enhance treatment outcomes compared to chemotherapy alone. It targets patients who have shown a partial or complete response to initial chemotherapy and immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed metastatic nasopharyngeal carcinoma who have responded to initial chemotherapy and immunotherapy.
Not a fit: Patients with a history of head and neck radiotherapy or those with autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with metastatic nasopharyngeal cancer.
How similar studies have performed: Previous studies have shown promising results with similar combinations of treatments, but this specific approach is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenzhen
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Shenzhen, China (Recruiting)
Study contacts
- Study coordinator: Li Ma, MD
- Email: ml_1990@126.com
- Phone: +8675566618168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.