locally advanced unresectable renal clear cell carcinoma or distant metastasis
Conditions
Interventions
Test group:Aminophylline combined with sunitinib malate capsule was taken orally
Sponsors
Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subject screening must meet all of the following criteria to be admitted to the study. If there are multiple clinical laboratory results during the screening period, the results closest to the enrollment date must be used to demonstrate eligibility for inclusion in the study. 1. The patients voluntarily participated in this study, signed the informed consent, had good compliance, and cooperated with follow-up visits; Note: Subject must be able to understand and willing to sign a written informed consent, a signed written informed consent must be obtained prior to the commencement of any steps related to this trial, and all acute toxicity of any prior treatment has returned to =90g/L; 2) Neutrophil absolute value (ANC) >=1.5*10^9/L; 3) Platelet (PLT) >=80*10^9/L. (2) Biochemical examination shall meet the following standards: 1) Total bilirubin (TBIL) <=1.5 times the upper limit of normal value (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of 2.5 or less ULN, such as with liver metastasis, ALT and AST 5 or less ULN. 3), serum creatinine (Cr) of 1.5 or less ULN or creatinine clearance rate (CCr) or 60 ml/min. 8. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should consent to patients who must use contraception during the study period and for six months after the study period ends.
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal coagulation function (INR>1.5*ULN, APTT>1.5*ULN) and bleeding tendency; 2. People who are allergic to aminophylline or sunitinib malate capsules should be prohibited; 3. Intracranial metastasis; 4. Pregnant or lactating women; 5. Other malignant tumors in the past 3 years; 6. Patients with dyspnea caused by malignant pleural effusion or abdominal effusion, NCI CTC AE grade 2 or above; 7. Any condition that, in the opinion of the Investigator, may impair the subject or prevent the Subject from meeting or performing the study requirements. 8. Patients who had previously received antiangiogenic targeted therapy, such as sunitinib, sorafenib, bevacizumab, famitinib, apatinib, regafenib, or not limited to the above drugs. 9. Present or present with other malignant tumors within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)); 10. With multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction); Patients with any severe and/or uncontrolled disease, including: 11. Patients with poorly controlled blood pressure (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg) with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTC >=480ms), and congestive heart failure grade 2 (New York Heart Association (NYHA) classification); 12. Active or uncontrolled severe infection (>=CTC AE grade 2 infection); 13. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral therapy; 14. Renal failure requiring hemodialysis or peritoneal dialysis; 15. Have a history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 16. Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); 17. Patients whose urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein quantity > 1.0 g; 18. Patients with epileptic seizures requiring treatment; Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders; 19. Participated in clinical trials of other antitumor drugs within four weeks; 20. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;overall survival;Exploration of biomarkers related to patient efficacy; | — |
Countries
China
Contacts
Public ContactLiu Junli
Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed