NCT04524884

Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II Study

The Efficacy and Safety of Anti-PD-1 Antibody Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of the combination of Toripalimab and Surufatinib for Locally Advanced Thyroid Cancer.

Detailed description

Surufatinib (HMPL-012, previously named sulfatinib) is a small-molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony-stimulating factor 1 receptor. A multi-center , opened, Phase II study have identified the efficacy and safety of Surufatinib in advanced medullary thyroid Carcinoma ( MTC) and iodine-refractory differentiated thyroid carcinoma (DTC).Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Surufatinib wiht Toripalimab in locally advanced differentiated thyroid cancer as neoadjuvant therapy.

Conditions

• Thyroid Cancer

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: 2020-10-01
• Primary completion: 2022-04-30
• Completion: 2022-09-30
• First posted: 2020-08-24
• Last updated: 2020-08-24

Locations

1 site across 1 country: China