Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCancer Hospital of Guangxi Medical University

About this trial

This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

Eligibility criteria

Qualifiers

Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor

staged as rT3-4N0-1M0或rT1-4N2-3M0 (according to the 8th AJCC edition)

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

Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L

Disqualifiers

Age older than 65, or younger than 18 years old

Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.

Patients with positive HCV antibody.

Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.

Trial design

Treatments tested in this trial

  • Toripalimab

Treatment groups

204 Participants
are divided into 2 treatment groups