NCT04557020

Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	PD-1 antibody	neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
DRUG	Gemcitabine	neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
DRUG	Cisplatin	neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
RADIATION	IMRT	70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions

Timeline

• Start date: 2020-12-30
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-09-21
• Last updated: 2024-05-01

Locations

7 sites across 1 country: China