Propranolol Adjuvant Treatment of Bladder Cancer: a Randomized Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 主要终点
- two-year recurrence-free survival
研究概览
简要总结
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 a higher incidence rate in men than in women. In 2013, the incidence rate of bladder cancer was high in China, accounting for 2.02% of all new cases. Bladder cancer has become a major disease threatening people's life and health. Therefore, the exploration of the mechanism of the occurrence and development of bladder cancer and effective drugs has been an important focus of bladder cancer research. The current treatment of bladder cancer is mainly TURBT (transurethral resection of bladder tumour) resection and BCG, chemotherapy adjuvant treatment, but its recurrence and metastasis still exist, so this study aims to explore an effective drug treatment. The purpose of this study was to investigate the safety and efficacy of propranolol in adjuvant BCG therapy, and whether propranolol can effectively alleviate the metastasis and recurrence of bladder cancer and improve the survival time after bladder cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BCG
After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.
干预措施: BCG (Drug)
Propranolol plus BCG
After TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
干预措施: Propranolol Hydrochloride (Drug)
Propranolol plus BCG
After TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
干预措施: BCG (Drug)
结局指标
主要结局
two-year recurrence-free survival
时间窗: 24 months
次要结局
未报告次要终点
研究者
Yijing He
Associate Professor
Central South University