Neuroendocrine tumor
Conditions
Interventions
Experimental group:Apatinib and camrelizumab in combination with transcatheter arterial chemoembolization (CalliSpheres microsphere-loaded irinotecan embolization) therapy
Sponsors
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Gastrointestinal pancreatic neuroendocrine tumor (GEP-NET) patients with liver metastasis; liver metastases were unresectable (discussed by MDT group); with or without metastasis of other parts; 2. The pathological diagnosis was neuroendocrine tumor; 3. Three Disease progression after receiving = 3 months; 6. There was no important organ dysfunction, and the laboratory examination met the basic requirements of chemotherapy, molecular targeted therapy and immunotherapy.
Exclusion criteria
Exclusion criteria: 1. Functional NET and need to be accompanied by the use of long-acting somatostatin analogues to control symptoms; 2. Urine routine showed urinary protein 2+ or 24-hour urinary protein quantitative test showed urinary protein 1 g; 3. Serum potassium, calcium (corrected for ionotropic or albumin binding), or magnesium outside the normal range and clinically significant; 4. Hypertension that cannot be stably controlled by drugs is specified as: systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg; 5. The investigator judges the digestive tract diseases or states that may affect drug absorption; 6. Previous or current severe bleeding; 7. Cardiovascular diseases with significant clinical significance; 8. The electrocardiogram (ECG) showed a QTc interval of 480 ms; 9. Suffering from other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical resection, or carcinoma in situ of the cervix; 10. Anti tumor therapy was performed within 4 weeks before the start of study treatment, including but not limited to chemotherapy, radical radiotherapy, biological targeted therapy, immunotherapy, anti-tumor traditional Chinese medicine therapy, hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation; 11. Received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment; 12. Have taken drugs containing Hypericum perforatum components within 3 weeks before the first study medication, or have taken other strong inducers or inhibitors of CYP3A4 within the first 2 weeks; 13. Any clinically significant active infection, including but not limited to human immunodeficiency virus (HIV) infection; 14. Known significant history of liver disease, including but not limited to known hepatitis B virus (HBV) infection and HBV DNA positive (1 x 10^4/ml) , and hepatitis C virus infection (HCV) and HCV RNA positive (1 x 10^3/ml), or liver cirrhosis, etc; 15. Surgery was performed within 28 days before enrollment, except biopsy, or the surgical incision did not completely heal; 16. Brain metastasis or spinal cord compression without surgery and or radiotherapy, or previously treated brain metastasis or spinal cord compression, but there is no clinical imaging evidence of stable disease; 17. The toxicity of previous anti-cancer treatment has not recovered to the level of 0 or 1 (except hair loss); 18. Participated in clinical trials of other drugs in the past 4 weeks and treated with corresponding experimental drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overallsurvival;Objective response rate; | — |
Countries
China
Contacts
Public ContactFu Qiang
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed