NCT04517214

Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

Phase II Study of Comparing Toripalimab Combined With GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic Nasopharyngeal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.

Detailed description

About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	PD-1 inhibitor
RADIATION	IMRT to the nasopharynx and neck	IMRT to the nasopharynx and neck
DRUG	Gemcitabine and Cisplatin Chemotherapy	Systemic chemotherapy
DRUG	Adjuvant chemotherapy with Capecitabine	Adjuvant chemotherapy after radiation

Timeline

• Start date: 2020-11-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2020-08-18
• Last updated: 2025-04-02

Locations

1 site across 1 country: China