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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05113355
Study type Interventional
Source Peking Union Medical College Hospital
Contact Chunmei Bai, M.D.
Phone 69158706
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 15, 2021
Completion date November 15, 2024

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