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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Chidamide
Drug20 mg of chidamide administered orally twice a week (BIW) 30 minutes after meals
Sintilimab
Drug200 mg of sintilimab administered via intravenous drip once every 3 weeks (Q3W)
Bevacizumab
Drug7.5 mg/kg of bevacizumab administered via intravenous drip once every 3 weeks (Q3W)
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: CAPExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
ORR
The primary endpoint of this study is the objective response rate (ORR) of chidamide + sintilimab + bevacizumab in the enrolled subjects, defined as the proportion of subjects achieving complete response (CR) or partial response (PR) evaluated by the investigator based on RECIST v1.1.
Time frame
From date of first study treatment until disease progression, up to approximately 37 months.Secondary outcomes
1
PFS
Progression-free survival (PFS), defined as the time from the first study treatment to disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame
From date of first study treatment until disease progression, up to approximately 37 months.2
OS
Overall survival (OS), defined as the time from the first study treatment to death from any cause.
Time frame
From date of first study treatment until disease progression, up to approximately 37 months.3
DCR
Disease control rate (DCR), defined as the proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) evaluated by the investigator based on RECIST v1.1.
Time frame
From date of first study treatment until disease progression, up to approximately 37 months.4
DOR
Duration of response (DOR), defined as the time from first documentation of objective response (CR/PR) to disease progression or death, whichever occurs first.
Time frame
From date of first study treatment until disease progression, up to approximately 37 months.Sponsors and contacts
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Source ClinicalTrials.gov