Bladder cancer
Conditions
Interventions
experimental group:Apatinib + gemcitabine + cisplatin
Sponsors
Tangdu Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged more than 55 years old; 2. in strict accordance with clinical diagnosis or muscle invasive urothelial cancer pathology or cytology, and at least one measurable lesion (spiral CT scan length diameter greater than or equal to 10mm); the largest tumor less than 15cm; 3. Urothelial carcinoma with indications of cystectomy (medication before surgery, tumor shrinkage, or missed chance of surgery, chemotherapy plus targeted drugs); 4. A radical cystectomy has been performed on one case of recurrence after surgery, with distant recurrence and metastasis (lungs, bones, etc.); 5. bladder urothelial carcinoma is indicated by cystectomy, but bladder surgery is performed for other reasons 6. not treated by other targeted drugs; 7. ECOG PS score, 0-2; 8. TNM staging was stage T2-T4; 9. expected survival more than 5 years; 10. the main organs function properly, that is, the following standards: (1) routine blood test: (14 days before screening, no blood transfusion, no G-CSF, no medication) HB = 90 g/L); ANC = 1.5 * 10^9/L); PLT = 80 * 109/L); (2) biochemical examination: (14 days without losing ALB) ALB = 29 g/L); ALT and AST<5ULN; TBIL = 1.5ULN); only one of the two indicators of the Child-Pugh rating, albumin and bilirubin, to be allowed to 2 points; 11. Participants volunteered to join the study, signed informed consent, with good compliance and followed up.
Exclusion criteria
Exclusion criteria: 1. received any targeted medication before participating in the study; 2. bladder non muscular invasive urothelial carcinoma; 3. a large number of clinical symptoms of hematuria, and hematuria difficult to control patients; 4. patients with high blood pressure and who were unable to fall within normal range by antihypertensive medications (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); 5. patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 MS); 6. according to the NYHA standard III to IV cardiac dysfunction or echocardiography: LVEF (left ventricular ejection fraction) was less than 50%; 7., there are a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs); 8. groups before 4 weeks appear larger than CTCAE (see Annex 6) grade 3 hemorrhage [not gastrointestinal cancer, this writing will be more appropriate, mainly excluded patients at risk of bleeding; 9. abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before the study; 10. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy; 11. patients with central nervous system metastasis or known brain metastases have been reported; 12. objective evidence of past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment; 13. urine routine showed that urinary protein is more than + + or confirm the urine protein in 24 hours, 1 g; 14. pregnant or lactating women, fertile patients, unwilling or unable to adopt effective contraceptive measures; 15. there is a history of mental illness or psychotropic substance abuse; 16. patients with bone metastases had received palliative radiotherapy (radiotherapy range > 5% bone marrow area) within 4 weeks before the study; 17. the researchers judged other cases that might affect clinical studies and the outcome of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| TTP;DCR;DCR; | — |
Primary
| Measure | Time frame |
|---|---|
| PFS;OS;Quality of life score; | — |
Countries
China
Contacts
Public ContactHe Wang
Tangdu Hospital of Air Force Military Medical University
Outcome results
None listed