NCT05854849

Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC

A Multicenter, Phase 3 Clinical Trial of Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	200mg, D1, Q3W, iv drip.
DRUG	Gemcitabine	1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.
DRUG	Cisplatin	80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.
DRUG	Apatinib	250mg, PO, QD

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2023-05-11
• Last updated: 2023-05-11

Locations

1 site across 1 country: China