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Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
A Prospective Multicenter Phase II Clinical Trial of Apatinib Mesylate Tablets Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Clinical Trial Summary

The study is to evaluate the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma after IMRT with concurrent chemotherapy,including The Overall Response Rate (ORR), Progression-free survival (PFS),Overall survival (OS),and Toxicities.

Clinical Trial Description

PRIMARY OBJECTIVES: To determine the clinical efficacy of apatinib mesylate tablets combined with PD-1 in the treatment of recurrent and metastatic nasopharyngeal carcinoma. SECONDARY OBJECTIVES: Ⅰ.To explore the adjuvant medication regimen of recurrent and metastatic nasopharyngeal carcinoma. Ⅱ.Provide high-level evidence-based medical evidence for the new individualized treatment strategy of nasopharyngeal carcinoma patients. OUTLINE: Eligible patients begin to use apatinib mesylate tablets and PD-1, apatinib mesylate tablets at the recommended dose of 250mg,orally, QD, continuous administration, 4 weeks (28 days) as an observation cycle. Until the disease progressed or unbearable adverse reactions appeared. If missed medication occurs during the medication period, it is confirmed that the next medication time is less than 12 hours, then there will be no replenishment. The recommended dose of PD-1 is 200mg/time, Q2W, intravenous injection, 4 weeks (28 days) as an observation cycle, until disease progression or intolerable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04350190
Study type Interventional
Source Guilin Medical University, China
Contact
Status Completed
Phase Phase 2
Start date January 14, 2021
Completion date September 15, 2022
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