Status:
UNKNOWN
Propranolol Adjuvant Treatment of Bladder Cancer
Lead Sponsor:
Central South University
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with 200000 deaths and...
Eligibility Criteria
Inclusion
- Ages 18 to 75
- Patients with pathologically confirmed non-muscle invasive bladder cancer (T1 / Ta high grade / CIS), according to the 2004 WHO classification criteria
- No evidence of patients with muscular invasive disease
- American Oncology Group ECOG score \<2
- Patients' expected survival time should be more than 3 months
- Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 \^ 9 / L; absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L Platelet count (PLT) ≥100 × 10 \^ 9 / L; total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase ( ALT) ≤ 2.5 × ULN; if abnormal liver function is due to tumor liver metastasis, AST or ALT ≤ 5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN; international standardized ratio (INR) or plasma prothrombin time PT) ≤1.5 × ULN
- Blood pressure with acceptable surgery: blood pressure greater than 90 / 60mmHg, resting heart rate greater than 60 beats / min
- Volunteer to participate in clinical research; fully understand, inform, and sign the consent form; willing to follow and have the ability to complete all test procedures
Exclusion
- Contraindications for propranolol: bronchial asthma, cardiogenic shock, cardiac block (II-III degree Atrioventricular conduction block), severe or acute heart failure, sinus bradycardia
- In use or have used any beta-blockers for disease reasons in the past two years
- Patients with other malignancies within 5 years before enrollment, in addition to cervical carcinoma in situ and cured skin basal cell carcinoma with appropriate treatment
- Immunodeficiency, such as patients with HIV infection or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- Patients with tumor brain metastases and bone marrow metastases were excluded, and patients with liver metastases and lung metastases could be included
- Participants who have participated in clinical studies of drugs other than BCG within 4 weeks
- Patients with a history of allergy to propranolol
- Alcohol, drug or substance abuse history in the past year
- Subject has an active infection or an unexplained fever during screening, before the first dose\> 38.5 degrees(According to the researcher's judgment, the subjects can be enrolled due to the fever caused by the tumor)
- Any situation that the investigator believes may increase the risk of the subject or interfere with clinical trials
Key Trial Info
Start Date :
September 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2024
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04493489
Start Date
September 6 2020
End Date
September 6 2024
Last Update
July 30 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.