Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm
NCT05113355 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2021-11-24
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.
Conditions
- Neuroendocrine Tumors
- Neuroendocrine Tumor Grade 3
- Neuroendocrine Carcinoma
- Neuroendocrine Neoplasm
Interventions
- 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.
Sponsors & Collaborators
-
The First Affiliated Hospital of Xiamen University
collaborator OTHER -
Harbin Medical University
collaborator OTHER -
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Chunmei Bai, M.D. · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-17
- Primary Completion
- 2022-11-15
- Completion
- 2024-11-15
Countries
- China
Study Locations
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