Adebrelimab and Chemoradiotherapy in High-risk LANPC

Last updated: January 13, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Nasopharyngeal Cancer

Carcinoma

Treatment

Adebrelimab

Clinical Study ID

NCT06349889
MA-NPC-II-004
  • Ages 18-65
  • All Genders

Study Summary

This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).

Eligibility Criteria

Inclusion

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 andplatelet count ≥100×10e9/L.

  5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit ofnormal (ULN), and bilirubin ≤ 1.5×ULN.

  6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gaultformula).

  7. Patients must be informed of the investigational nature of this study and givewritten informed consent.

  8. Women of childbearing potential (WOCBP) who are sexually active must be willing toadhere to effective contraception during treatment and for 1 year after the lastdose of study drug. Men who are sexually active with WOCBP must be willing to adhereto effective contraception during treatment and for 1 year after the last dose ofthe study drug

Exclusion

Exclusion Criteria:

  1. Age > 65 or < 18.

  2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3copies/ml or 200IU/ml

  3. Hepatitis C virus (HCV) antibody positive

  4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated withreplacement 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, inhaleor topical corticosteroid will be allowed.

  6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patientswith 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 alive vaccine in the near future.

  9. Is pregnant or breastfeeding.

  10. Prior malignancy within 5 years, except in situ cancer, adequately treatednon-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 illnessor domestic/social factors, deemed by the investigator to be likely to interferewith a patient's ability to sign informed consent, cooperate and participate in thestudy, or interferes with the interpretation of the results.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Adebrelimab
Phase: 2
Study Start date:
July 23, 2024
Estimated Completion Date:
May 01, 2028

Study Description

The trial plans to enroll patients with stage IVA+T3N2M0 (AJCC 8th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Adebrelimab in induction chemotherapy and adjuvant chemotherapy. Adebrelimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in induction therapy and for 9 cycles in adjuvant therapy.

Connect with a study center

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

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