NCT05747729

A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.

A Single-arm, Open-label, Single-center Clinical Trial of Surufatinib and Serplulimab Combined With Standard Chemotherapy (Platinum/Etoposide) in Neuroendocrine Carcinoma.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. This clinical trial evaluates the efficacy and safety of surufatinib and serplulimab combined with standard chemotherapy (Platinum/Etoposide) in neuroendocrine carcinoma.

Conditions

• Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib and Serplulimab	Surufatinib: Safety lead-in : Oral, QD, starting dose 250 mg, adjusted according to DLT. Dose expansion: administration according to the dose determined in the safety lead-in phase. Serplulimab: 300 mg intravenous infusion on day 1, repeated every 3 weeks.

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-02-28
• Completion: 2026-02-28
• First posted: 2023-02-28
• Last updated: 2023-02-28

Locations

1 site across 1 country: China