NCT04955886

Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 .

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib(HMPL-012)	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 .

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2021-07-09
• Last updated: 2021-07-09

Locations

2 sites across 1 country: China