NCT05417139

Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
OTHER	Immunotherapy+induction chemotherapy+radiotherapy	All enrolled patients received Sintilimab (200mg, d1, q3w) + GP (gemcitabine 1000mg / m2, d1, d8 + cisplatin 80mg / m2, d1, q3w) for 4-6 cycles followed by radiotherapy of primary site and cervical metastasis, and Sintilimab (200mg, q3w) treatment was continued during and after radiotherapy until disease progression or toxicity or up to 2 years.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2025-07-01
• First posted: 2022-06-14
• Last updated: 2022-06-14

Locations

1 site across 1 country: China