Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
NCT07518602 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-04-08
Summary
This is a single-arm, multicenter phase Ⅱ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab in subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy. The primary purpose is to assess the objective response rate (ORR) of chidamide + sintilimab + bevacizumab in the above-mentioned subjects, with a planned enrollment of 34 subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy.
Conditions
- Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
Interventions
- DRUG
-
Chidamide
20 mg of chidamide administered orally twice a week (BIW) 30 minutes after meals
- DRUG
-
Sintilimab
200 mg of sintilimab administered via intravenous drip once every 3 weeks (Q3W)
- DRUG
-
7.5 mg/kg of bevacizumab administered via intravenous drip once every 3 weeks (Q3W)
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Feng Wang, MD, PhD · Sun Yat-sen Univesity Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-27
- Primary Completion
- 2028-03-27
- Completion
- 2028-09-27
Countries
- China
Study Locations
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