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Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Efficacy and Safety of Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm, Phase 2 Trail

Clinical Trial Summary

The purpose of this study is to explore the efficacy and safety of combination of Apatinib and Camrelizumab regimen in treating recurrent or metastatic nasopharyngeal carcinoma patients who were resistant to PD-1 antagonists.

Clinical Trial Description

Currently, there is still no uniform treatment regimen in treating recurrent or metastatic nasopharyngeal carcinoma patients who failed to first-line platinum-based chemotherapy. Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Immunotherapy combined with other treatment regimens for recurrent or metastatic nasopharyngeal carcinoma is a strategy that needs to be urgently explored. Vascular endothelial growth factor (VEGF) is an important target in the treatment of nasopharyngeal carcinoma. Apatinib, a small-molecule tyrosine kinase inhibitor selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), has shown strong clinical utility. Previous clinical studies have confirmed that apatinib shows antitumor activity and tolerable toxicity in recurrent or metastatic nasopharyngeal carcinoma. Tumor vascular normalization and immune reprogramming interact synergistically and could enter a mutually reinforcing virtuous cycle by improving tumor microenvironment. The current national comprehensive cancer network (NCCN) guidelines also recommend Nivolumab and Pembrolizumab as second-line treatment for recurrent or metastatic nasopharyngeal carcinoma. More and more evidences show that immunotherapy combined with anti-angiogenesis therapy has a synergistic effect, and Camrelizumab combined with apatinib has achieved initial effect in solid tumors. Based on this, this study aims to evaluate the efficacy and safety of Camrelizumab combined with apatinib in the patients with recurrent or metastatic nasopharyngeal carcinoma who failed to first-line anti-PD-1 monoclonal antibody, to provide new evidence for individualized comprehensive treatment in nasopharyngeal carcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04548271
Study type Interventional
Source Sun Yat-sen University
Contact Haiqiang Mai
Phone 86-20-87343380
Email maihq@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date September 2020
Completion date October 2023
View Details
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