neuroendocrine cancer
Conditions
Interventions
Experimental group:Adbelimab combined with Apatinib Mesylate and Albumin Paclitaxel
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Age: 18-75 years old; 3. Diagnosed by histopathology with advanced (locally advanced unresectable or distant metastatic) neuroendocrine tumors; 4. Failed first-line systemic treatment; 5. Patient has measurable lesions (according to RECIST 1.1 criteria); 6. Major organ functions are normal, meeting the following criteria: (1) Blood routine test standards must meet: HB >= 90 g/L (no blood transfusion in the past 28 days); ANC >= 1.5×10^9/L; PLT >= 80×10^9/L. (2) Biochemical tests must meet the following standards: BIL =60 ml/min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%). 7. ECOG performance status 0 or 1; 8. Expected survival over 12 weeks; 9. Women of childbearing age must agree to use contraceptive measures during the study and for 6 months after the study (such as intrauterine device, contraceptive pills, or condoms); negative serum or urine pregnancy test within 7 days before enrollment, and must not be breastfeeding; men must agree to use contraceptive measures during the study and for 6 months after the study.
Exclusion criteria
Exclusion criteria: 1.There are known uncontrolled or symptomatic active central nervous system (CNS) metastases, manifested as clinical symptoms, cerebral edema, spinal cord compression, malignant meningitis, leptomeningeal disease, and/or progressive growth. For central nervous system metastases that have received adequate treatment and whose neurological symptoms can recover to baseline levels at least 2 weeks prior to enrollment (excluding residual signs or symptoms related to CNS treatment), they can be included. In addition, subjects must discontinue corticosteroids or receive stable doses =150 mmHg or diastolic blood pressure >=100 mmHg); (2) Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval >=480 ms), and grade I cardiac dysfunction; (3) Active or uncontrolled severe infections; (4) Liver diseases such as decompensated liver disease, active hepatitis B (HB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Disease Control Rate;Objective Response Rate;overall survival;Duration of relief; | — |
Countries
China
Contacts
Public ContactLijie Song
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed