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Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Efficacy and Safety of Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma : a Prospective, Single Arm and Multicenter Trial

Clinical Trial Summary

A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.

Clinical Trial Description

This study adopt Simon's two-stage Optimal designs method based on the primary endpoint of objective response rates. 4 patients were planned for the first stage. If one or more responses were observed, an additional 8 patients were to be accrued for a total of 12 patients. If 4 or more of the 12 patients achieved an objective response, then this study was designated worthy of additional investigation.Considering a 10% abscission rate, a total of 14 patients were included. Surufatinib（250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04955886
Study type Interventional
Source Fujian Cancer Hospital
Contact Sufang Qiu, MD
Phone 13609589163
Email sfqiu@126.com
Status Not yet recruiting
Phase Phase 2
Start date August 2021
Completion date August 2023
View Details
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