Bladder carcinoma
Conditions
Interventions
single-arm:hydrogen-rich normal saline combined with bladder cancer chemotherapy
Sponsors
Shenzhen Luohu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in the trial and sign a written informed consent form; (2) Aged >=18 years and <=75 years, male or female; (3) Histopathological diagnosis of non-muscle invasive bladder urothelial carcinoma, according to the 2014 edition of the CUA bladder cancer diagnosis and treatment guidelines for patients with high-risk recurrence or progression risk; (for patients considering secondary resection, After the completion of the second electric resection and the pathological results confirmed to be a high-risk non-muscle invasive bladder urothelial carcinoma, and then included in the study). (4) ECOG score: 0-2 points.
Exclusion criteria
Exclusion criteria: (1) Any of the following conditions: those with immunodeficiency or damage (such as AIDS patients), who are using immunosuppressive drugs or radiation therapy, who may cause systemic inflammatory reactions; those who are allergic to bladder cancer chemotherapy drugs; People with fever and acute infectious diseases, including active tuberculosis, or those undergoing anti-tuberculosis treatment; accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; (2) Patients with other genitourinary tumors or other organ tumors; (3) Patients with myometrial invasive bladder urothelial carcinoma (T2 and above); (4) Those who have received chemotherapy, radiotherapy, or immunotherapy in the past 4 weeks (except for intravesical infusion chemotherapy immediately after surgery); (5) Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those who are scheduled to be pregnant during the trial (including maternal male partners); (6) Had a history of bladder contracture or a bladder functional volume of less than 200 mL; (7) Known or suspected intraoperative bladder perforation; (8) Severe urethral stricture can not be placed into the cystoscope; (9) Tumor metastasis was found by pelvic CT examination or full physical examination; (10) There is still gross hematuria before enrollment, and it is suspected that the wound is not healed or the urinary tract mucosa is damaged; (11) Patients with cystitis, or who have received other bladder infusion medications and have a severe bladder irritation that is expected to affect the study; (12) Low immune function, acquired, congenital immunodeficiency disease, or a history of organ transplantation; (13) Suffering from severe cardiovascular and cerebrovascular diseases such as myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or lung Embolism and other inability to tolerate TURBT surgery; (14) There are obvious major visceral dysfunctions, such as: creatinine > 1.5 times the upper limit of the normal range, AST, ALT, total bilirubin > 1.5 times the upper limit of the normal range; (15) The body temperature of fever exceeds 38 °C, and there are obvious active infections that may affect clinical trials such as acute pneumonia, active tuberculosis, and subjects with severe urinary tract infections; (16) Those with hereditary or acquired coagulopathy or who are using anticoagulant drugs; (17) Patients with severe hypertension who have not been controlled after intervention (systolic blood pressure >= 180 mmHg, diastolic blood pressure >= 110 mmHg), or those with severe complications of hypertension, or those with serious complications of diabetes; (18) Decreased bone marrow hematopoiesis: subjects with white blood cells <3.0×10^9/L, or hemoglobin less than 80 g/L, or neutrophils <1.5×10^9/L, or platelets <75×10^9/L, or Other blood system diseases; (19) Participated in clinical trials of other drugs within 3 months prior to enrollment; (20) Opioid or alcohol dependent persons are known; (21) The investigator believes that there may be any situation that increases the risk of the subject or interferes with the performance of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate;Relapse free survival; | — |
Countries
China
Contacts
Public ContactWu Song
Shenzhen Luohu People's Hospital
Outcome results
None listed