Adaptive immunotherapy for nasopharyngeal carcinoma

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 is a phase 3, single‑center randomized trial that adapts post‑induction treatment based on tumor response and circulating EBV‑DNA. All participants receive three cycles of GP induction chemotherapy combined with a PD‑1 inhibitor, then are stratified by post‑induction response and EBV‑DNA level. Low‑risk patients with complete or partial response and undetectable EBV‑DNA are randomized to radical radiotherapy alone versus concurrent chemoradiotherapy to compare event‑free survival and toxicity. High‑risk patients with stable disease or detectable EBV‑DNA are randomized to adjuvant capecitabine plus immunotherapy versus adjuvant immunotherapy to test for improved event‑free survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-65 years;
* Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
* Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
* ECOG performance status: 0-1;
* Adequate bone marrow function: white blood cell count \> 4 × 10⁹/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10⁹/L;
* Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min;
* Normal thyroid function, amylase, lipase, pituitary function;
* Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;
* Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
* Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.

Exclusion Criteria:

* T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
* Disease progression after induction therapy;
* Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
* Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
* Active tuberculosis;
* Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
* History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;
* Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;
* Uncontrolled cardiac disease;
* Pregnant or lactating women;
* History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;
* Known allergy to macromolecular protein preparations or any component of toripalimab;
* Active infection requiring systemic treatment within one week prior to enrollment;
* Administration of a live vaccine within 30 days before the first dose of toripalimab;
* History of organ transplantation;
* Contraindications to MRI examination, which would prevent the completion of required imaging;
* Any other condition deemed by the investigators to potentially compromise patient safety or compliance.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Ling-Long Tang
• Email: tangll@sysucc.org.cn
• Phone: 02087343840

Similar studies

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

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• Becotatug Vedotin plus Anti-PD-1 as maintenance for recurrent/metastatic NPC

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• Intratumoral EDS01 plus toripalimab for recurrent or metastatic head and neck cancer

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• Maintenance immunotherapy with deferred salvage radiotherapy after response to chemoimmunotherapy in recurrent nasopharyngeal cancer

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• Becotatug vedotin added to radiation and adjuvant therapy for locally advanced nasopharyngeal cancer with a poor response to induction chemo‑immunotherapy

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• IMRT-only treatment for stage IB nasopharyngeal cancer without high-risk features

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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.