NCT05015621

A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma

A Phase 3, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Surufatinib Plus Toripalimab Versus FOLFIRI as a Secondline Treatment in Patients With Advanced Neuroendocrine Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Surufatnib combined with Toripalimab compared with FOLFIRI in the treatment of advanced neuroendocrine carcinoma

Detailed description

This is a randomized, controlled, open-label, multicenter, phase III clinical study designed to evaluate the efficacy and safety of surufatnib combined with toripalimab compared with FOLFIRI in patients with advanced neuroendocrine carcinoma who have progression of disease or intolerable toxicity after previous 1st-line chemotherapy.

Conditions

• Advanced Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib plus Toripalimab	Surufatinib is a tablet in the form of 50mg, oral, once a day; Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.
DRUG	5-fluorouracil, Calcium folinate and Irinotecan	Irinotecan 180 mg/m\^2, Calcium folinate 400 mg/m\^2, 5-FU total 2800 mg/m\^2 will be administrated once two weeks.

Timeline

• Start date: 2021-09-18
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2021-08-20
• Last updated: 2023-12-13

Locations

1 site across 1 country: China