NCT05165407

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of High-grade Advanced-neuroendocrine Neoplasms: a Single Arm, Open-label, Multi Center, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University · Academic / Other
• 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 Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm

Detailed description

The study population is about 40 patients with high-grade advanced-neuroendocrine neoplasm, who fails or cannot tolerate standard therapies. Surufatinib 250 mg once a day (QD) will be orally administrated, Sintilimab 200mg will be intravenously administered every 3 weeks and IBI310 1mg/kg will be intravenously administered every 6 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Sintilimab, the upper time limit for treatment is 2 years. The primary objective is objective response rate (ORR) of Sintilimab combined with IBI310 and Surufatinib in patients with advanced high-grade advanced-neuroendocrine neoplasm.

Conditions

• Neuroendocrine Neoplasm

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg will be intravenously administered on Day 1 of each cycle
DRUG	IBI310	IBI310 1mg/kg be intravenously administered on Day 1 of every 2 cycle
DRUG	Surufatinib	Surufatinib 250mg will be taken orally once daily continuously

Timeline

• Start date: 2022-07-12
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2021-12-21
• Last updated: 2025-03-14

Locations

2 sites across 1 country: China