Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the efficacy and safety of tislelizumab for stage IVA locally advanced nasopharyngeal carcinoma combined with induction chemotherapy and concurrent chemoradiotherapy, followed by maintenance therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

1. The subjects are not limited by gender, age from 18 to 70 years old;

2. Histopathologically confirmed non-keratinizing squamous cell carcinoma of the nasopharynx;

3. Locally advanced nasopharyngeal squamous cell carcinoma diagnosed as T4 or N3 stage according to AJCC 8th edition staging;

4. ECOG score 0-1;

5. without distant metastasis;

6. This treatment must be the first course of treatment, and has not received any anti-tumor treatment such as radiotherapy and chemotherapy, immune or biological therapy in the past.

7. The expected survival is expected to be no less than 6 months.

8. No contraindications to chemotherapy, immunotherapy and radiotherapy;

Exclusion Criteria:

1. Received any systemic anti-tumor therapy for target lesions in the past;

2. Previously experienced head and neck radiation therapy;

3. Those who have received any immunotherapy such as anti-PD-1/PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody in the past;

4. Subjects who have been vaccinated with anti-tumor vaccines or other drugs with immunomodulatory functions (such as interleukin-2, thymosin, lentinan, etc.) within 1 month before enrollment, or who will be vaccinated with live attenuated vaccines. subject;

5. Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted;

6. Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment;