Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 18, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with metastatic nasopharyngeal carcinoma (NPC), a type of cancer that has spread beyond its original site. Researchers want to find out if combining immunotherapy (which helps the immune system fight cancer) and chemotherapy (medications that kill cancer cells) with radiotherapy (using high-energy rays to target tumors) can improve patient outcomes. The goal is to see if this combination can help more patients respond positively to treatment and live longer without their cancer worsening.

To be eligible for this trial, participants need to be between 18 and 75 years old and have been diagnosed with metastatic NPC. They should have shown some response to at least three cycles of chemotherapy combined with immunotherapy. Patients must also meet certain health criteria, such as having adequate organ function and being able to give informed consent. Those who have had previous head and neck radiotherapy or have certain other health conditions may not qualify. If eligible, participants can expect to receive a new treatment regimen and will be closely monitored for its effects and any side effects throughout the trial.

Gender

ALL

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