Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Eligibility criteria

Qualifiers

Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;

Not suitable for surgery;

Histologic diagnosis of NPC (WHO II/III);

TNM stage rII-IVa (AJCC/UICC 8th);

Disqualifiers

Treated with anti-tumor Chinese medicine treatment;

Have recurrence with local necrosis;

Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;

Unexplained fever > 38.5, except for tumor fever;

Trial design

Treatments tested in this trial

  • Toripalimab
  • Chemotherapy
  • Intensity modulated radiotherapy

Treatment groups

212 Participants
are divided into 2 treatment groups

Sponsors and collaborators