Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT07518602
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Chidamide — DRUG
    20 mg of chidamide administered orally twice a week (BIW) 30 minutes after meals
  • Sintilimab — DRUG
    200 mg of sintilimab administered via intravenous drip once every 3 weeks (Q3W)
  • Bevacizumab — DRUG
    7.5 mg/kg of bevacizumab administered via intravenous drip once every 3 weeks (Q3W)

Study Details

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.

Key Dates

First listed
Apr 8, 2026
Start date
Mar 27, 2026
Status verified
Apr 2026
Primary completion
Mar 27, 2028
Completion
Sep 27, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAP
    chidamide + sintilimab + bevacizumab

Primary Outcome Measure

ORR [ Time Frame: From date of first study treatment until disease progression, up to approximately 37 months. ]

Central Contacts

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