NCT06323239

SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma

Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	SBRT	SBRT for metastatic lesions
RADIATION	Low-dose Radiotherapy (LDRT)	LDRT for metastatic lesions
DRUG	Toripalimab	6 cycles for combined therapy. Toripalimab maintenance for 1 year.
DRUG	Gemcitabine	6 cycles for combined therapy.
DRUG	Cisplatin	6 cycles for combined therapy.
RADIATION	IMRT	IMRT for primary lesion

Timeline

• Start date: 2024-07-15
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2024-03-21
• Last updated: 2024-08-20

Locations

1 site across 1 country: China