Actively Recruiting
Evaluation of Efficacy and Safety of Chidamide, Sintilimab, and Bevacizumab in Advanced Extrapulmonary Neuroendocrine Carcinoma After First-Line Therapy Failure
Led by Sun Yat-sen University · Updated on 2026-04-08
34
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of a combination treatment using chidamide, sintilimab, and bevacizumab for people with advanced extrapulmonary neuroendocrine carcinoma who have not responded to first-line standard therapy. This single-arm, multicenter phase II study aims to measure the objective response rate of this treatment in 34 participants with this condition. The study is sponsored by Sun Yat-sen University and focuses on patients with unresectable or metastatic disease who meet specific health criteria. All participants will receive the same treatment regimen consisting of 200 mg of sintilimab given intravenously every three weeks, 20 mg of chidamide taken orally twice a week after meals, and 7.5 mg/kg of bevacizumab administered intravenously every three weeks. The intravenous drugs are given in sequence, with sintilimab infused first, followed by bevacizumab. Treatment continues until disease progression, unacceptable side effects, withdrawal, or other protocol reasons, with disease progression confirmed by specific imaging criteria. There is no control group in this study. Participants will undergo regular imaging tests such as CT or MRI scans every six weeks for the first 24 weeks, then every nine weeks thereafter to monitor tumor response. Safety assessments include physical exams, vital signs, laboratory tests, and heart monitoring throughout the study and follow-up periods. After treatment ends, a safety check occurs 30 days later, and survival follow-up continues every 90 days until death or study completion. Primary and secondary outcomes include response rate, progression-free survival, overall survival, disease control, duration of response, and incidence of adverse events.
CONDITIONS
Brief 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 discontinuation due to toxicity
- 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 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 any anti-angiogenic therapy or histone deacetylase (HDAC) inhibitors
- Use of investigational drugs within 4 weeks before study treatment
- Participation in another interventional clinical study
- Recent anti-tumor therapy within 3 weeks before study treatment
- Recent radiotherapy within 4 weeks before study treatment or unresolved radiation-related toxicity
- Recent systemic immunosuppressive drugs except low-dose corticosteroids
- Live attenuated vaccine use within 4 weeks before or during the study
- Major surgery within 4 weeks before study treatment or unhealed wounds
- Symptomatic central nervous system metastases except stable treated cases
- Active autoimmune disease or primary immunodeficiency
- Active tuberculosis or recent anti-tuberculosis treatment
- Interstitial lung disease requiring corticosteroids
- Active hepatitis B or C infection
- Known HIV infection or syphilis
- Severe uncontrolled infection or recent hospitalization for infection
- Severe malnutrition requiring intravenous nutrition unless corrected
- Symptomatic congestive heart failure or uncontrolled arrhythmia
- Uncontrolled high blood pressure despite treatment
- Recent arterial thromboembolic events or severe thromboembolism
- Significant liver disease including cirrhosis Child-Pugh B or C
- Recent serious gastrointestinal conditions
- Uncontrolled metabolic or severe medical conditions increasing study risk
- Hereditary bleeding or coagulation disorders
- Recent life-threatening bleeding events
- High bleeding risk conditions
- Recent cerebrovascular accident
- Use of high-dose aspirin or platelet inhibitors before treatment
- Use of anticoagulants or thrombolytics before treatment except prophylactic
- Symptomatic or drainable fluid accumulations
- History of other malignancies except certain treated cancers
- History of organ or stem cell transplantation
- Known hypersensitivity to study drugs
- Pregnant or breastfeeding women
- History of alcoholism or drug abuse
- Any other condition increasing study risk or interfering with results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 37 months or until disease progression or other discontinuation reasons
Participants receive chidamide orally twice a week, and sintilimab and bevacizumab intravenously once every 3 weeks. Treatment continues until disease progression, intolerable toxicity, withdrawal, or other protocol-specified reasons.
Intravenous drug visits every 3 weeks; oral medication twice weekly
Duration - Up to study completion, approximately 37 months
After treatment ends, participants undergo a safety follow-up about 30 days after the last dose, followed by survival follow-up every 90 days to monitor overall survival and subsequent therapies until death or study end.
1 safety follow-up visit and survival follow-up every 90 days (can be by telephone)
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
Z
Zhiqiang Wang, MD, PhD
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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