NCT04169672

Study of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid Tumors

A Phase II, Open-label, Single-arm, Multi-center Study of the Efficacy and Safety of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Surufatinib single agent or Surufatinib combined with Toripalimab in patients with advanced solid tumors.

Detailed description

The study population is about 260 patients with advanced solid tumors, who fails or can not tolerate standard therapies, or for whom no effective standard therapy is available, or who refuses standard therapies. This study includes two arms. One is that Surufatinib single agent 300mg once a day (QD) will be orally administrated in patients with advanced neuroendocrine carcinoma (NEC). In another arm Surufatinib 250 mg QD will be orally administrated and Toripalimab 240mg will be intravenously administered every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Toripalimab, the upper time limit for treatment is 2 years. The primary objective is safety of safety run-in (about 6 patients) and objective response rate (ORR) of Surufatinib single agent in patients with advanced NEC or Surufatinib combined with Toripalimab in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib is a tablet in the form of 50mg, oral, once a day.
DRUG	Toripalimab	Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.

Timeline

• Start date: 2019-12-26
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2019-11-20
• Last updated: 2023-03-02

Locations

2 sites across 1 country: China