Pulmonary carcinoid (typical carcinoid) and pulmonary atypical carcinoid are two types of pulmonary neuroendocrine tumors. They originate from the neuroendocrine cells in the lungs. Typical Carcinoid: Disease Description: This is a low-grade malignant tumor with slow growth and a low risk of metastasis. The tumor cells are well-differentiated with a characteristic organoid structure. Comm
Conditions
Interventions
Intervention group:Surufatinib combined with temozolomide
Sponsors
The Second Affiliated hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; no gender restriction, voluntary participation in the trial with signed informed consent form. 2. Pathologically confirmed diagnosis of advanced pulmonary neuroendocrine tumor (typical carcinoid or atypical carcinoid), which is not eligible for curative surgical resection. 3. No prior systemic anti-tumor therapy received for this disease. 4. ECOG performance status score: 0-1. 5. At least one CT-measurable lesion according to RECIST 1.1 criteria. 6. Major organ and bone marrow functions are essentially normal. 7. Expected survival >=12 weeks. 8. Check indicators: A) Complete blood count: White blood cells >=4.0 x 10^9/L, neutrophils >=1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >=90g/L; B) International Normalized Ratio (INR) =60 mL/min; E) Normal cardiac function, Left Ventricular Ejection Fraction (LVEF) >=50% as measured by two-dimensional echocardiography. 9. At least one month prior to the study treatment, brain metastases must be asymptomatic or treated and stable after discontinuing steroids and anticonvulsants. 10. Patients of childbearing age (including female and male patients' female partners) must take effective contraceptive measures. 11.It is expected that those with good compliance will be able to follow up on the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Tumor histologically or cytologically confirmed as Grade 3 (G3) pulmonary neuroendocrine carcinoma (e.g., small cell lung cancer, large cell neuroendocrine carcinoma); 2. Received the following treatments within 4 weeks prior to treatment: including but not limited to surgery, chemotherapy, radical radiotherapy, biological targeted therapy, immunotherapy, or investigational drugs from other clinical trials; 3. Pregnant or lactating women; 4. Presence of pleural effusion or ascites causing respiratory syndrome (dyspnea >= CTCAE grade 2); 5. Symptomatic brain or meningeal metastases (unless they have received local radiotherapy or surgery more than 6 months ago and have stable, controlled disease); 6. Severe infection occurring within 4 weeks prior to treatment (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever > 38.5°C during screening/prior to the first dose; 7. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 8. Urine routine shows urinary protein >= 2+and 24-hour urinary protein quantification>1.0g; 9. Within the first 3 months of treatment, there are obvious clinical bleeding symptoms or tendencies (bleeding>30 mL within 3 months, accompanied by vomiting blood, black stool, and rectal bleeding), hemoptysis (fresh blood>5 mL within 4 weeks), etc. Or treatment for venous/venous thrombosis events that occurred within the previous 6 months, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Or long-term anticoagulant therapy with warfarin or heparin is required, or long-term antiplatelet therapy (aspirin >= 300 mg/day or clopidogrel >= 75 mg/day) is needed; 10. Active heart disease, including myocardial infarction and severe/unstable angina, occurred 6 months before treatment. Echocardiography shows a left ventricular ejection fraction450 ms, females>470 ms); 11. The patient has had other malignant tumors within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 12. Known to be allergic to the investigational drug or any of its excipients; 13. Active or uncontrolled severe infections; A) Known human immunodeficiency virus (HIV) infection; B) Known history of clinically significant liver disease, including viral hepatitis [known as carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (>1 × 10^4 copies/mL or>2000 IU/ml); C) Known hepatitis C virus infection (HCV) and HCV RNA positivity (>1 × 10^3 copies/mL), or other hepatitis or cirrhosis; 14. Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory examination abnormalities that, based on the researcher's judgment, have reason to suspect that the patient has a certain disease or state that is not suitable for the use of the study drug (such as having seizures and requiring treatment), or will affect the interpretation of the study results, or put the patient in a high-risk situation; 15. Researchers believe that there are other situations that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overbal Survival;Obiective Response Rate;Disease Control Rate.; | — |
Countries
China
Contacts
Public ContactDongyong Yang
The Second Affiliated hospital of Fujian Medical University
Outcome results
None listed