Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

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

Treatment groups

243 Participants
are divided into 3 treatment groups

Sponsors and collaborators