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Nasopharyngeal Cancinoma (NPC)Phase 3NCT07238569

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

A Phase 3 study testing Adebrelimab (PD-L1 inhibitor), Cisplatin (100mg/m2) and Intensity-modulated radiotherapy in people with Nasopharyngeal Cancinoma (NPC) and Nasopharangeal Cancer, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Adebrelimab (PD-L1 inhibitor), Cisplatin (100mg/m2) and Intensity-modulated radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 23 May 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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：
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  • 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
  • For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits
  • 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).

Who cannot join

  • 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.
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  • 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
  • Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
  • History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
  • Known hypersensitivity to macromolecule protein products or any component of adebrelimab.
  • Active infections requiring systemic treatment within 1 week prior to enrollment.
  • Administration of live vaccines within 30 days prior to the first dose of adebrelimab.
  • Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
  • History of organ transplantation or hematopoietic stem cell transplantation.
  • Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jun Ma, M.D contact

+862087343469

majun2@mail.sysu.edu.cn

Lei Chen, M.D. contact

chenlei@sysucc.org.cn

About this study

Official title: Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

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.

Read the detailed description

This study will enroll patients with stage II-III LANPC (AJCC 9th edition, excluding T3N0-1). After three cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab), eligible patients with persistent EBV DNA or stable disease will be randomized 1:1. All patients will undergo CCRT followed by adjuvant therapy. The control arm will receive five cycles of adebrelimab. The experimental arm will receive five cycles of adebrelimab in combination with capecitabine, which will be administered for one year.

Being tested
Adebrelimab (PD-L1 inhibitor), Cisplatin (100mg/m2), Intensity-modulated radiotherapy, Capecitabine
Keywords
adebrelimab, PD-L1 antibody, chemoradiotherapy, capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adebrelimab (PD-L1 inhibitor)Drug

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

  • 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

  • Intensity-modulated radiotherapyRadiation

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

  • CapecitabineDrug

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

Study groups in NCT07238569
Study groupRoleWhat they receive
adebrelimab plus capecitabineExperimentalPatients 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.
Receives: Drug: Adebrelimab (PD-L1 inhibitor); Drug: Cisplatin (100mg/m2); Radiation: Intensity-modulated radiotherapy; Drug: Capecitabine
adebrelimabActive comparatorPatients 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.
Receives: Drug: Adebrelimab (PD-L1 inhibitor); Drug: Cisplatin (100mg/m2); Radiation: Intensity-modulated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 year

Secondary outcomes (7)

  1. Overall survival (OS)

    From date of randomization until the date of death from any cause, whichever came first, assessed up to 74 months

    Measured: 3 years

  2. Distant metastasis-free survival (DMFS)

    From date of randomization until the date of first documented distant metastasis, whichever occurred first, assessed up to 74 months.

    Measured: 3 years

  3. Locoregional recurrence-free survival (LRRFS)

    From date of randomization until the date of first documented locoregional recurrence, whichever occurred first, assessed up to 74 months.

    Measured: 3 years

  4. Tumor response

    Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians

    Measured: 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

  5. Adverse events (AEs) and serious adverse events (SAEs)

    Graded according to CTCAE V5.0.

    Measured: 3 years

  6. Quality of life (QoL)

    The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual. For the functional scales and the global health status scale, a higher score represents a better level of functioning or quality of life. For the symptom scales, a higher score indicates a greater severity of symptoms.

    Measured: week 1, 6, 24, 60, 72

  7. Failure-free survival (FFS) within different subgroups

    analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. >4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion23 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238569
Sponsor's protocol ID
2025-FXY-346-FLK
Status last verified
Nov 2025
First submitted
16 Nov 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Complete de-identified patient data set will be submitted onto an online platform.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adebrelimab (PD-L1 inhibitor), Cisplatin (100mg/m2) and Intensity-modulated radiotherapy in people with Nasopharyngeal Cancinoma (NPC) and Nasopharangeal Cancer, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Ma, M.D (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival (FFS) (time frame: 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07238569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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