Actively Recruiting
Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors
Led by Shanghai Chest Hospital · Updated on 2026-01-22
96
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate if chemotherapy works with surufatinib to treat pulmonary neuroendocrine tumors. It will also learn about the safety of this combination regimen. The main questions it aims to answer are: Does chemotherapy combined with surufatinib could bring more survival benefits (ie. higher response rate or longer survival time) for patients with pulmonary neuroendocrine tumors? Is this combination regimen safe? Researchers will compare chemotherapy plus surufatinib with surufatinib monotherapy to see if this combination regimen works to treat pulmonary neuroendocrine tumors. Participants will: Take chemotherapy(Etoposide+Carboplatin, EC or Capecitabine+Temozolomide, CAPTEM) plus surufatinib or surufatinib monotherapy every 3 or 4 weeks as a cycle. Visit the clinic once every cycle for checkups and tests. Tumor assessment is performed every 2 cycles. Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.
CONDITIONS
Official Title
Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate by signing consent
- Aged between 18 and 75 years, any gender
- Have at least one measurable tumor lesion
- Confirmed diagnosis of pulmonary neuroendocrine tumor (typical or atypical carcinoid) with positive neuroendocrine markers
- No prior systemic therapy except early stage chemotherapy completed at least 6 months ago
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (0-2 if amputee)
- Expected to live at least 12 weeks
- Adequate blood counts and organ function as defined by study
- Use effective contraception during and for 6 months after the study if of childbearing potential
You will not qualify if you...
- Previous treatment with surufatinib or other anti-angiogenic drugs
- Received systemic anti-tumor therapy or radiotherapy within 4 weeks before enrollment
- Participated in unapproved drug trials within 4 weeks before enrollment
- Recent surgery or invasive procedures affecting healing within 4 weeks
- Blood clotting abnormalities beyond specified limits
- Significant electrolyte imbalances
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Conditions preventing oral intake of surufatinib
- Active gastrointestinal ulcers, bleeding, or diseases that increase bleeding risk
- Recent bleeding events or blood clot-related conditions within defined time frames
- Serious heart diseases including recent heart attack or heart failure NYHA class >2
- Other cancers within past 5 years except certain skin or cervical cancers
- Active infections including HIV, active hepatitis B or C
- Active or unstable brain metastases
- Unresolved toxicity from prior cancer treatments except hair loss and low lymphocytes
- Pregnant or breastfeeding
- Recent blood transfusions or blood product treatments
- Any other clinical or lab issues deemed unsuitable by investigators
- Significant proteinuria above study thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
4
Shanghai chest hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
B
Baohui Han, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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