Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Jan 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with nasopharyngeal carcinoma, a type of cancer located in the upper throat behind the nose. The study is looking at how well a combination of chemotherapy (called GP) and a medication known as tislelizumab work together. This combination is being tested both before surgery (neoadjuvant therapy) and after surgery (adjuvant therapy) to see if it can improve outcomes for patients with advanced stages of this cancer.

To be eligible for the trial, participants need to be between 18 and 70 years old and must have a confirmed diagnosis of a specific type of nasopharyngeal carcinoma. Eligible patients should not have received any previous cancer treatments and must meet certain health criteria, ensuring their body can handle the study medications. Throughout the trial, participants will receive close monitoring and support from the research team. It’s important to know that this study is currently active but not recruiting new participants, meaning that they are currently seeing patients who have already enrolled.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must be informed of the investigational nature of this study and give written informed consent.
• • 2. Age ≥ 18 years and ≤70 years,men or non-pregnant women.
• • 3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
• • 4. Tumor staged as III-IVA (AJCC 8th, except T3N0，T3N1(Only retropharyngeal lymph nodes metastasized).
• • 5. No previous anti-tumor treatment.
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• • 7. Adequate marrow function:White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
• • 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
• Exclusion Criteria:
• • 1. Patients with recurrent or metastatic nasopharyngeal carcinoma.
• • 2. Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
• • 3. Prior therapy with radiation or systemic chemotherapy.
• • 4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
• • 5. Seropositivity for human immunodeficiency virus (HIV).
• • 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
• • 7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies.
• • 8. Patients with immunodeficiency disease or a history of organ transplantation.
• • 9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks.
• • 10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
• • 11. Patients with severe, uncontrolled disease or infections.
• • 12. Received other research drugs or in other clinical trials at the same time.
• • 13. Refuse or fail to sign the informed consent .
• • 14. Patients with other treatment contraindications.
• • 15. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
• • 16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml.
• • 17. Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative.
• • 18. Patients who were known to be intolerable or allergic to treatment drug.