NCT04547088

Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

Efficacy and Safety of Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm, Phase 2 Trail

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of a combination of Camrelizumab and Apatinib regimen in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

Detailed 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 a second-line treatment for recurrent or metastatic nasopharyngeal carcinoma. More and more evidence show that immunotherapy combined with anti-angiogenesis therapy has a synergistic effect, and Camrelizumab combined with apatinib therapy has achieved the 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 platinum-based chemotherapy, to provide new evidence for individualized comprehensive treatment in nasopharyngeal carcinoma.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Anti-PD-1 targeted immunotherapy
DRUG	Apatinib	A small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-09-14
• Last updated: 2020-09-14

Locations

1 site across 1 country: China