Combining Adebrelimab with Chemotherapy and Radiation for Advanced Nasopharyngeal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: majun2@mail.sysu.edu.cn
• Phone: +862087343469

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Induction chemotherapy followed by guided radiation for EBV-related nasopharyngeal cancer

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• Comparing GP chemotherapy with and without adebrelimab for 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.

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• Using Nivolumab with chemotherapy for nasopharyngeal carcinoma in children and adults

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  Recruiting at 10 sites Phase 2 German Society for Pediatric Oncology and Hematology GPOH gGmbH · Aachen and 30 other locations · NCT06019130

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

  This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

• Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.