Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Eligibility criteria

Qualifiers

Age: 18 Years to 70 Years;

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III

Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1

T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;

Disqualifiers

Patients have evidence of relapse or distant metastasis

Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

Patients with positive cervical lymph nodes

Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).

Trial design

Treatments tested in this trial

  • Without prophylactic neck irradiation
  • PD-1 antibody (Toripalimab)
  • Cisplatin

Treatment groups

59 Participants
are divided into 1 treatment group

Sponsors and collaborators