Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Launched by WEI JIANG · Oct 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with locally advanced nasopharyngeal carcinoma, a type of cancer found in the area where the throat meets the nose. The trial is comparing two different treatment approaches: one group of patients will receive standard chemotherapy and radiation, while the other group will receive the same chemotherapy and radiation plus an experimental drug called Camrelizumab. All patients will undergo a specific type of radiation therapy called intensity-modulated radiotherapy (IMRT).

To be eligible for the trial, patients must be between 18 and 70 years old, have a confirmed diagnosis of nasopharyngeal carcinoma that is staged as III-IVA, and have good overall health. Participants can expect to receive treatment over several weeks, including three cycles of chemotherapy followed by radiation, and those in the Camrelizumab group will continue with the drug for additional cycles. It's important for patients to understand that this trial is part of research to find better treatments, and they will need to provide informed consent to participate. If you or a loved one is considering joining this study, discussing eligibility and any questions with a healthcare provider is a great next step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with histologically confirmed nasopharyngeal carcinoma.
• • 2. Tumor staged as III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0).
• • 3. Eastern Cooperative Oncology Group performance status ≤1.
• • 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥80g/L and platelet count ≥80×10e9/L.
• • 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
• • 6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
• • 7. Patients must be informed of the investigational nature of this study and give written informed consent.
• • 8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
• Exclusion Criteria:
• • 1. Age \> 70 or \< 18.
• • 2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
• • 3. Hepatitis C virus (HCV) antibody positive
• • 4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• • 5. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
• • 6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
• • 7. Has a known history of interstitial lung disease.
• • 8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
• • 9. Is pregnant or breastfeeding.
• • 10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
• • 11. Has known allergy to large molecule protein products or any compound of camrelizumab.
• • 12. Has a known history of human immunodeficiency virus (HIV) infection.
• • 13. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.