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