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Adebrelimab and Chemoradiotherapy in High-risk LANPC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Adebrelimab and Chemoradiotherapy in High-risk LANPC

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

NCT06349889•Sun Yat-sen University

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (4)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

July 23, 2024

Primary Completion Date

May 1, 2028

Completion Date

May 1, 2028

Last Updated

January 15, 2025

Enrollment

ESTIMATED participants

Conditions

Nasopharyngeal CarcinomaNasopharyngeal Cancer

Interventions

Adebrelimab

DRUG

Contacts

Jun Ma, M.D.

CONTACT

+862087343469 majun2@mail.sysu.edu.cn

Lei Chen, M.D.

CONTACT

chenlei@mail.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adebrelimab and Chemoradiotherapy in High-risk LANPC

Inclusion Criteria

Exclusion Criteria

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