NCT07388836

Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma

A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.
DRUG	Toripalimab	Toripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-05-01
• First posted: 2026-02-05
• Last updated: 2026-02-05