medium and high risk non-muscularly invasive bladder cancer
Conditions
Interventions
N-CWS Group:800ugN-CWS??
BCG vaccine:BCG??120mg
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age:18-75 years old, male or female; 2.The ECOG physical condition score is 0-2; 3.Pathology (histologically or cytologically), this was a primary non-muscular invasive urothelial carcinoma of the bladder, patients who were assessed as having a medium-high risk of recurrence or progression according to the 2014 CUA Guidelines for the Diagnosis and Treatment of Bladder Cancer ,For patients considering secondary resection,it can be included in the study after the completion of the second electrotomy and the pathological findings confirmed as medium-high risk non-muscular invasive urothelial carcinoma of the bladder; 4.The subjects voluntarily participated in this study and signed the informed consent. They had good compliance and cooperated with the treatment and follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not included in the study: 1.Immunodeficiency or impairment (eg of AIDS patients),immunosuppressive drugs or radiation therapy are being used,ossible to cause systemic BCG disease response,Allergic to BCG or other ingredients,People suffering from fever and acute infectious diseases, including active tuberculosis, or receiving anti-tuberculosis treatment; Complicated with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; 2.Previous use of immunomodulatory drugs within 14 days preoperatively ,did not include nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses.(That is, not more than 10 mg/ day of prednisolone or equivalent pharmacological doses of other corticosteroids); 3.Known immunodeficiency, acquired or congenital immunodeficiency disease, or a history of organ transplantation; 4.Known allergy to the study drug or any excipient thereof; Main ingredients include: mycoic acid, galactose arabinose, mucin, squalene; 5.Complicated with tumors of other genitourinary system or other organs; 6.Muscular infiltrating urothelial carcinoma of the bladder (stage T2 and above); 7.A history of bladder contracture or bladder functional volume less than 200ml; 8.Intraoperative bladder perforation is known or suspected; 9.Severe urethral stricture can not be placed cystoscope; 10.Tumor metastasis was found in pelvic CT examination or general physical examination; 11.Before enrollment, there was gross hematuria, and it was suspected that the surgical wound was not healed or the mucosa of the urinary tract was damaged; 12.Patients with cystitis or previous treatment with other bladder perfusion agents and severe bladder irritation were expected to be affected by this study's evaluators; 13.Suffering from severe cardiovascular and cerebrovascular diseases, such as myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, having symptoms congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism cannot tolerate TurBT surgery; 14.There were significant major visceral organ dysfunction, such as creatinine > 1.5 times the upper limit of the normal range, AST, ALT, and total bilirubin BBB>1.5 times the upper limit of the normal range, etc.; 15.Body temperature over 38?,Significant active infections such as acute pneumonia, active tuberculosis, and severe urinary tract infections may affect clinical trials in subjects; 16.Hereditary or acquired coagulation disorders or those taking anticoagulant drugs; 17.Severe hypertension that is not controlled after intervention treatment(Systolic blood pressure >= 180mmHg,Diastolic blood pressure >= 110mmHg),or severe complications of hypertension,or there are serious complications of diabetes (Poor drug control ,FBG > 10mmol/L); 18.The hematopoietic function of bone marrow was reduced:The subjects blood leukocytes < 3.0 x 10^9/L,or hemoglobin < 80g/L,or neutrophils < 1.5 x 10^9/L,or platelet < 75 x 10^9/L,Or have other diseases of the blood system; 19.Known opioid or alcohol dependence; 20.Pregnant or lactating women, women of child-bearing age who are not using effective contraceptives, and those who plan to become pregnant during the trial (including male subjects with partner conception); 21.The presence of other serious physical or mental disorders or laboratory test abnormalities may increase the ris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 1,2,3,5 year recurrence rate;The incidence of urinary tract infections; | — |
Countries
China
Contacts
Public ContactPeng Zhang
West China Hospital, Sichuan University
Outcome results
None listed