Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed locally advanced, unresectable, or metastatic extrapulmonary neuroendocrine carcinoma (NEC).
Failure of first-line standard systemic therapy, with documented disease progression during or after treatment by imaging or clinical evidence (e.g., cytology of new ascites or pleural effusion). Patients who discontinued first-line therapy due to intolerable toxicity are eligible.
At least one measurable lesion per RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Prior exposure to any anti-angiogenic therapy or histone deacetylase (HDAC) inhibitor.
Received any investigational drug within 4 weeks before the first dose of study treatment.
Simultaneously participating in another interventional clinical study (observational or follow-up studies are allowed).
Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, embolization, etc.) within 3 weeks before first dose.
Trial design
Treatments tested in this trial
- Chidamide
- Sintilimab
- Bevacizumab
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov