PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase III, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.

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

Details

• Lead Sponsor: Guangxi Medical University
• Collaborators: Affiliated Hospital of North Sichuan Medical College; First People's Hospital of Yulin; Fourth Affiliated Hospital of Guangxi Medical University; Guigang People's Hospital; Hainan People's Hospital; Second affiliated hospital of Guangxi Medical University; Wuzhou Red Cross Hospital; Yulin Red Cross Hospital
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).

2. Original clinical staged as T4NanyM0 or TanyN3M0 (according to AJCC 8th edition) or Plasm EBV-DNA≥4000copies/ml, with no evidence of distant metastasis.

3. Eastern Cooperative Oncology Group performance status ≤1.

4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L, and platelet count ≥100×10e9/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 the 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 > 65 or < 18.

2. Receiving radiotherapy or chemotherapy or targeted therapy or immunotherapy previously.

3. Severe cerebrovascular disease/canker/psychosis.

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 who 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. Suffering from active infection diseases and in need of treatment.

8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.

9. 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 PD-1 antibody.

12. Has a known history of the 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.