Spots Global Cancer Trial Database for Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

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Trial Identification

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

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

Study ID: NCT04350190

Conditions

Nasopharyngeal Carcinoma

Interventions

Apatinib mesylate tablet

PD-1

Study Description

Brief 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.

Detailed 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.