About this trial
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
Eligibility criteria
Qualifiers
Age between 18 and 70 years, male or non-pregnant female.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
ECOG performance status score of 0 or 1.
Disqualifiers
Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
Prior history of radiotherapy or systemic chemotherapy.
Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
Trial design
Treatments tested in this trial
- GP plus Toripalimab Induction chemotherapy+CCRT
- TP plus Toripalimab Induction chemotherapy+CCRT
- TPC plus Toripalimab Induction chemotherapy+CCRT