Comparing GP chemotherapy with and without adebrelimab for nasopharyngeal carcinoma

GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma

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

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, adebrelimab, pembrolizumab, nivolumab, camrelizumab, toripalimab, immunotherapy
• Locations: 12 sites (Foshan, Guangdong and 11 other locations)
• Trial ID: NCT06455410 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of combining neoadjuvant GP chemotherapy with the immune checkpoint inhibitor adebrelimab compared to GP chemotherapy alone in patients with high-risk locoregionally advanced nasopharyngeal carcinoma. The trial aims to determine if the addition of adebrelimab can enhance treatment outcomes, particularly in terms of response rates and survival. Participants will receive three cycles of GP chemotherapy followed by concurrent chemoradiotherapy. The study will include patients aged 18 to 65 with specific tumor staging and no prior anti-tumor treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed nonkeratinizing nasopharyngeal carcinoma and specific tumor staging.

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

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with nasopharyngeal carcinoma.

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

Eligibility criteria

Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent.
2. Age ≥ 18 years and ≤65 years, men or non-pregnant women.
3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
4. Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th).
5. No previous anti-tumor treatment.
6. Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
7. Adequate marrow function: White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) ≤2×upper limit of normal (ULN).
9. Adequate renal function: creatinine clearance rate ≥ 60 ml/min or Creatinine ≤ 1.5× upper limit of normal value.

Exclusion Criteria:

1. Patients with recurrent or metastatic nasopharyngeal carcinoma.
2. Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
3. Prior therapy with radiation or 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 or 200 IU/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

Foshan, Guangdong and 11 other locations

• Foshan First People's Hospital — Foshan, Guangdong, China (Not_yet_recruiting)
• Affiliated cancer hospital and institute of guangzhou medical university — Guangzhou, China (Not_yet_recruiting)
• Sun Yat-Sen Memorial Hospital — Guangzhou, China (Not_yet_recruiting)
• The affiliated panyu central hospital of guangzhou medical university — Guangzhou, China (Not_yet_recruiting)
• ZhuJiang Hospital of Southern Medical University — Guangzhou, China (Not_yet_recruiting)
• Liuzhou Workers Hospital — Liuzhou, China (Not_yet_recruiting)
• Guangxi Medical University Affiliated Cancer Hospital — Nanning, China (Not_yet_recruiting)
• Cancer hospital of Shantou university medical college — Shantou, China (Not_yet_recruiting)
• Cancer hospital Chinese academy of medical sciences, Shenzhen center — Shenzhen, China (Not_yet_recruiting)
• The second people's hospital of Shenzhen — Shenzhen, China (Recruiting)
• The university of Hongkong - Shenzhen hospital — Shenzhen, China (Not_yet_recruiting)
• Guangdong Medical School First Affiliated Hospital — Zhangjiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hai-Qiang Mai, MD, PhD

Conditions Nasopharyngeal Carcinoma