Actively Recruiting
Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
Led by Sun Yat-sen University · Updated on 2026-04-08
34
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced, unresectable, or metastatic extrapulmonary neuroendocrine carcinoma
- Failure of first-line standard systemic therapy with documented disease progression or discontinued due to toxicity
- At least one measurable lesion according to 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 procedures
- Age between 18 and 75 years
- Life expectancy of at least 12 weeks
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential
- Adequate organ and bone marrow function within 7 days before enrollment without recent support treatments
You will not qualify if you...
- Prior exposure to anti-angiogenic therapy or histone deacetylase (HDAC) inhibitors
- Use of investigational drugs within 4 weeks before first dose
- Participation in another interventional clinical study
- Recent anti-tumor therapy within 3 weeks or radiotherapy within 4 weeks before first dose
- Residual radiation toxicity requiring corticosteroids
- Use of systemic immunosuppressive drugs except low-dose corticosteroids
- Recent live attenuated vaccines
- Major surgery or unhealed wounds within 4 weeks before first dose
- Unresolved toxicity from prior therapy above grade 1 except alopecia or lab abnormalities
- Symptomatic or untreated central nervous system metastases
- Active autoimmune disease requiring systemic therapy within 2 years
- Active tuberculosis or recent treatment
- Interstitial lung disease requiring corticosteroids
- Active hepatitis B or C infection
- Known HIV infection or syphilis
- Severe uncontrolled infections
- Significant malnutrition requiring intravenous nutrition
- Symptomatic congestive heart failure or uncontrolled arrhythmia
- Uncontrolled high blood pressure
- Recent arterial thromboembolic events
- Recent severe thromboembolism
- Liver cirrhosis Child-Pugh B or C
- Recent gastrointestinal complications or surgeries
- Uncontrolled metabolic or severe medical conditions
- Bleeding disorders or recent life-threatening bleeding
- High bleeding risk
- Recent cerebrovascular accident
- Use of high-dose aspirin or platelet inhibitors
- Use of anticoagulants or thrombolytics recently
- Symptomatic or drainable pleural, pericardial, or ascitic effusions
- History of other malignancies except in remission or treated non-melanoma skin cancer
- History of organ or stem cell transplantation
- Known hypersensitivity to study drugs
- Pregnant or breastfeeding women
- History of alcoholism or drug abuse
- Any other acute or chronic condition increasing study risk or interfering with results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
F
Feng Wang, MD, PhD
CONTACT
Z
Zhiqiang Wang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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