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Peramprizumab Combined With GP ± Anlotinib as Neoadjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Peramprizumab Combined With GP ± Arotinib Induction Therapy + Concurrent Chemoradiotherapy + Adjuvant Peramprizumab in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Clinical Trial

Clinical Trial Summary

The purpose of this study is to explore the efficacy and safety of a combination of GP chemotherapy and Peramprizumab ± Anlotinib in neoadjuvant therapy combined with Peramprizumab in adjuvant therapy of locoregionally advanced nasopharyngeal carcinoma patients.

Clinical Trial Description

Radiotherapy combined with chemotherapy is the standard treatment method for locally advanced NPC. In the 2020 National Comprehensive Cancer Network (NCCN) guidelines, GP regimen induction chemotherapy combined with concurrent chemoradiotherapy has been established as evidence-based grade 2A. Based on the results of phase 3 clinical trials, the addition of PD-1 monoclonal antibody to GP chemotherapy as a first-line treatment for patients with recurrent or metastatic nonkeratinizing NPC provided superior PFS, ORR and DoR than GP alone while maintaining a manageable safety profile. Therefore, the combination of PD-1 monoclonal antibody in GP induction chemotherapy may further improve the prognosis of patients with locally advanced NPC. There is a complex interaction between tumor immune microenvironment and tumor vascular remodeling. Anti-PD-1 monoclonal antibody combined with anti-VEGF have synergistic effect and inhibit tumor growth. Peramprizumab is a new type of PD-1 monoclonal antibody. It has the characteristics of strong antigen binding and slow dissociation rate, which can maintain the antitumor activity of T cells. Anlotinib is a multi-target tyrosine kinase inhibitor (TKI). It can effectively inhibit a variety of receptors, including vascular endothelial growth factor receptor (VEGFR), and block tumor angiogenesis more comprehensively. Based on the above research background, this study adopts a two-stage design: Stage I (Pick the Winner Study): For patients with locally advanced NPC, the complete response rate (CR) of tumor after induction chemotherapy was compared between the two groups of patients receiving GP + peramprizumab and GP + peramprizumab + arotinib before radiotherapy. The regimen with higher CR rate was the winner at this stage. Stage II ( Cohort Expansion Study): The 3-year failure free survival (FFS) of patients in the winning regimen of expansion cohort was calculated through long-term follow-up and compared with the data in previous trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05193617
Study type Interventional
Source Sun Yat-sen University
Contact Hai-Qiang Mai, Ph.D
Phone 8613570027338
Email maihq@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date January 20, 2022
Completion date January 1, 2027
View Details
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