Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary… (NCT07518602) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
China34 participantsStarted 2026-03-27
Plain-language summary
This is a single-arm, multicenter phase â…¡ 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Able to provide written informed consent and comply with study visits and procedures.
✓. Age ≥ 18 years and ≤ 75 years.
✓. Life expectancy ≥ 12 weeks.
✓. Women of childbearing potential and men with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.
Exclusion criteria
What they're measuring
1
ORR
Timeframe: From date of first study treatment until disease progression, up to approximately 37 months.
✕. 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.
✕. Received radiotherapy within 4 weeks before first dose.
✕. Residual radiation-related toxicity (e.g., pneumonitis, hepatitis, enteritis) from prior radiotherapy \> 4 weeks before first dose, including symptomatic cases or those requiring corticosteroids.
✕. Received systemic immunosuppressive drugs within 4 weeks before first dose, except topical/inhaled corticosteroids or physiological systemic corticosteroids (≤ 10 mg/day prednisone equivalent).
✕. Received or plans to receive live attenuated vaccines within 4 weeks before first dose or during the study.