Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma

NCT07238569 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-FXY-346-FLK
• Study Type: interventional
• Target: 516
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.

Conditions

Nasopharyngeal Cancinoma (NPC); Nasopharangeal Cancer

Keywords

adebrelimab; PD-L1 antibody; chemoradiotherapy; capecitabine

Outcome Measures

Primary Outcomes (1)

• Failure-free survival (FFS)

  From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first, assessed up to 74 months

  3 year

Secondary Outcomes (7)

• Overall survival (OS)

  3 years

• Distant metastasis-free survival (DMFS)

  3 years

• Locoregional recurrence-free survival (LRRFS)

  3 years

• Tumor response

  the time of completion of induction chemotherapy, radiotherapy, and adjuvant immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 74 weeks

• Adverse events (AEs) and serious adverse events (SAEs)

  3 years

Other Outcomes (2)

• Correlation between pre-treatment PD-L1 expression level and FFS

  3 years

• Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level

  3 years

Study Arms (2)

adebrelimab plus capecitabine

EXPERIMENTAL

Patients will receive definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with adebrelimab (1200 mg, d1) will be initiated for a total of 5 cycles, and capecitabine will be administered at 650 mg/m² orally twice daily for one year.

Drug: Adebrelimab (PD-L1 inhibitor); Drug: Cisplatin (100mg/m2); Radiation: Intensity-modulated radiotherapy; Drug: Capecitabine

adebrelimab

ACTIVE COMPARATOR

Patients will receive definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with adebrelimab (1200 mg, d1) will be initiated for a total of 5 cycles.

Drug: Adebrelimab (PD-L1 inhibitor); Drug: Cisplatin (100mg/m2); Radiation: Intensity-modulated radiotherapy

Interventions

Adebrelimab (PD-L1 inhibitor) DRUG

Adebrelimab 1200mg will be given every 3 weeks for 5 cycles in adjuvant chemotherapy

adebrelimab; adebrelimab plus capecitabine

Cisplatin (100mg/m2) DRUG

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

adebrelimab; adebrelimab plus capecitabine

Intensity-modulated radiotherapy RADIATION

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

adebrelimab; adebrelimab plus capecitabine

Capecitabine DRUG

Capecitabine was administered at 650 mg/m² orally twice daily for one year.

adebrelimab plus capecitabine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤65 years
• Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
• Eastern Cooperative Oncology Group performance score of 0-1.
• Tumor staged as II-III disease (AJCC 9th edition), excluding T3N0-1.
• Adequate marrow function: white blood cell count \> 4 × 10⁹/L hemoglobin \>90g/L and platelet count \>100×10⁹/L
• Adequate hepatic and renal function：
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN
• Alkaline phosphatase ≤ 2.5 × ULN
• clearance rate ≥ 60 ml/min
• Other laboratory and clinical criteria
• Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)
• For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required

You may not qualify if:

• Patients with persistent EBV DNA positivity or stable disease following 3 cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab).
• Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
• Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).
• Disease progression after induction chemotherapy
• Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
• Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
• Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.
• Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
• History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
• Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
• Uncontrolled cardiac conditions, such as:
• Heart failure with New York Heart Association (NYHA) classification ≥ Class II;
• Unstable angina;
• History of myocardial infarction within the past year;
• Supraventricular or ventricular arrhythmias requiring treatment or intervention

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Cisplatin; Radiotherapy, Intensity-Modulated; Capecitabine

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Jun Ma, M.D

CONTACT

+862087343469; majun2@mail.sysu.edu.cn

Lei Chen, M.D.

CONTACT

chenlei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 23, 2031
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share