Combining Adebrelimab with Chemotherapy and Radiation for Advanced Nasopharyngeal Cancer

Adebrelimab Combined with Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 2, Multicenter, Single-arm Clinical Trial

This study is testing if adding a new drug called Adebrelimab to standard chemotherapy and radiation can help people with advanced nasopharyngeal cancer feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Adebrelimab, prednisone, chemotherapy, radiation
• Locations: 4 sites (Xiamen, Fujian and 3 other locations)
• Trial ID: NCT06349889 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of Adebrelimab when used alongside induction chemotherapy and concurrent chemoradiotherapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma. Participants will undergo three cycles of induction chemotherapy with gemcitabine and cisplatin, followed by concurrent treatment with cisplatin and radiation, while receiving Adebrelimab. The treatment regimen includes Adebrelimab starting on day one of induction chemotherapy and continuing for a total of 12 cycles. The goal is to assess the safety and efficacy of this combined approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed stage IVA+T3N2M0 nasopharyngeal carcinoma and an Eastern Cooperative Oncology Group performance status of 1 or lower.

Not a fit: Patients with earlier-stage nasopharyngeal carcinoma or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating nasopharyngeal carcinoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients with histologically confirmed nasopharyngeal carcinoma.
2. Tumor staged as IVA+T3N2M0 (AJCC 8th).
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 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. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
3. Hepatitis C virus (HCV) antibody positive
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 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. Has a known history of interstitial lung disease.
8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
9. Is 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 Adebrelimab.
12. Has a known history of 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.

Where this trial is running

Xiamen, Fujian and 3 other locations

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Jun Ma, M.D. — Sun Yat-Sen University Cancer Center
• Study coordinator: Jun Ma, M.D.

Conditions Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; immunotherapy; Chemoradiotherapy; PD-L1