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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Anti-PD-1 targeted immunotherapy
A small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Objective response rate
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)
Time frame: 2 years
Disease control rate
A disease control rate is defined as either a confirmed CR or a PR or a SD, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Time frame: 2 years
Duration of response
Defined from date of first confirmed CR or a PR to date of first documentation of progression or death due to any cause, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Time frame: 2 years
Progression-free survival rate
Defined from date of registration to date of first documentation of progression or death due to any cause.
Time frame: 2 years
Overall survival rate
Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 2 years
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) as assessed by CTCAE v5.0.
Time frame: 2 years
PD-L1 expression on tumor and immune cells
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The efficacy of the combination of Camrelizumab and apatinib as measured by objective response, will be described in patients according to PD-L1 positive and PD-L1 negative.
Time frame: 2 years
VEGFR-2 expression in tumor
The impact of VEGFR-2 on efficacy of the combination of Camrelizumab and apatinib will be explored.
Time frame: 2 years