Combining GP chemotherapy with Tislelizumab for advanced nasopharyngeal carcinoma

Efficacy and Safety of of GP Chemotherapy Combined With Tislelizumab Neoadjuvant Therapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Trial

This study is testing if combining GP chemotherapy with Tislelizumab can help people with advanced nasopharyngeal cancer do better before their standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, tislelizumab, pembrolizumab, nivolumab, camrelizumab, toripalimab, tirelizumab, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04833257 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of a combination of GP chemotherapy and Tislelizumab as neoadjuvant therapy for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). The approach builds on established evidence that GP chemotherapy improves survival rates when combined with chemoradiotherapy. The trial aims to enhance treatment outcomes by incorporating an immune checkpoint inhibitor, Tislelizumab, which has shown promise in treating NPC. Participants will receive this combination therapy before standard treatment to assess its impact on tumor response and patient survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with confirmed nonkeratinizing nasopharyngeal carcinoma at stage III-IVa.

Not a fit: Patients with recurrent or metastatic nasopharyngeal carcinoma or those with keratinizing squamous cell carcinoma will not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown promising results with similar combinations of chemotherapy and immune checkpoint inhibitors in treating nasopharyngeal carcinoma.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation with Written informed consent.
2. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.
3. Histologically or cytologically confirmed with Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
4. Original clinical staged as III-IVa (according to the 8th AJCC edition), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
5. White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
6. 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) .
7. Adequate renal function: creatinine clearance rate≥60 ml/min .

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hai qiang Mai

Conditions Nasopharyngeal Carcinoma