Adaptive Immunotherapy for Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Radical radiotherapy of nasopharynx and neck
  • Capecitabine
  • Concurrent chemoradiotherapy (cCRT)
  • Toripalimab

Treatment groups

802 Participants
are divided into 4 treatment groups

Sponsors and collaborators