Using Tislelizumab with Chemotherapy for Advanced Nasopharyngeal Cancer

Neoadjuvant Chemotherapy Plus Tislelizumab Followed by Concurrent Chemoradiotherapy and Maintenance Therapy With Tislelizumab in Patients With Stage IVA Nasopharyngeal Carcinoma: A Single-arm, Phase II Trial

This study is testing if adding a new immune therapy called tislelizumab to standard chemotherapy can help people with advanced nasopharyngeal cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone, tislelizumab, pembrolizumab, nivolumab, camrelizumab, toripalimab, tirelizumab
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05448885 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of tislelizumab, an immune checkpoint inhibitor, in combination with induction chemotherapy and concurrent chemoradiotherapy for patients with stage IVA locally advanced nasopharyngeal carcinoma. The study aims to improve treatment outcomes by integrating tislelizumab into the standard treatment regimen, which includes platinum-based chemotherapy. Participants will receive tislelizumab as maintenance therapy following their initial treatment. The trial is designed to assess both the effectiveness of this combination therapy and its safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histopathologically confirmed non-keratinizing squamous cell carcinoma of the nasopharynx at T4 or N3 stage.

Not a fit: Patients who have previously received any systemic anti-tumor therapy or immunotherapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce recurrence in patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar immune checkpoint inhibitors in treating nasopharyngeal carcinoma, indicating potential for success in this approach.

Eligibility 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;

Where this trial is running

Beijing, Beijing

• National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Shiran Sun, Dr.

Conditions Nasopharyngeal Carcinoma