Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy and safety of a combination of GP chemotherapy and tislelizumab in neoadjuvant therapy combined with tislelizumab in adjuvant therapy of locoregionally advanced nasopharyngeal carcinoma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Hospital of Guangdong Medical College; Cancer Hospital of Guizhou Province; Hunan Cancer Hospital; Wuzhou Red Cross Hospital

Criteria

Inclusion Criteria:

1. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).

2. Tumor staged as III-IVA (AJCC 8th, except T3N0，T3N1(Only retropharyngeal lymph nodes metastasized).

3. Patients must be informed of the investigational nature of this study and give written informed consent.

4. Age ≥ 18 years and ≤65 years

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

6. Adequate marrow function:White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.

7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .

8. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.

9. 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. Patients with recurrent or metastatic nasopharyngeal carcinoma.

2. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.

3. Prior therapy with 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.