NCT05113355

Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm

Chidamide and Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of chidamide combined with sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.

Detailed description

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. If more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 patients will be treated.

Conditions

• Neuroendocrine Tumors
• Neuroendocrine Tumor Grade 3
• Neuroendocrine Carcinoma
• Neuroendocrine Neoplasm

Interventions

Type	Name	Description
DRUG	Chidamide	30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
DRUG	Sintilimab	200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-11-15
• Completion: 2024-11-15
• First posted: 2021-11-09
• Last updated: 2021-11-24

Locations

2 sites across 1 country: China