NCT07325539

LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC

Low-dose Radiotherapy (LDRT) Combined With Toripalimab and GP Chemotherapy for Recurrent/Metastatic Nasopharyngeal Carcinoma (LIGHT): A Single-Center, Open-Label, Single-Arm Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.

Conditions

• Nasopharyngeal Cancinoma (NPC)
• Nasopharangeal Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine(GEM)	Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 4-6 cycles
DRUG	Cisplatin	Cisplatin 80mg/m2, d1 of every cycle, every 3 weeks for 4-6 cycles
DRUG	Toripalimab	Toripalimab 240 mg, d1of every cycle, every 3 weeks for 4-6 cycles. Toripalimab maintenance, 240 mg, d1of every cycle, every 3 weeks until disease progression or unacceptable toxicity.
RADIATION	LDRT	Irradiation of the primary lesion and regional metastatic lymph nodes, 0.5 Gy per fraction for 4 fractions, d0-3, every 3 weeks for 4-6 cycles

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-09-01
• Completion: 2028-06-01
• First posted: 2026-01-08
• Last updated: 2026-04-13

Locations

1 site across 1 country: China