LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- LCS103 Safety
研究概览
简要总结
This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC. The study will include 60 participants randomized 1:1 to either the investigational or control arm.
Patients in the investigational arm will receive three oral tablets of LCS103 herbal formula twice daily for 1 year, in addition to the SOC recommended per risk group:
- Low Risk: Cystoscopic follow-up at 3 & 9 months and yearly thereafter.
- Intermediate Risk: 1-year intravesical instillations of BCG. Cystoscopic follow-up at 3 & 9 months, then biannually for 2 years and yearly thereafter.
- High Risk: 3-year intravesical instillations of BCG. Cystoscopy and urine cytology every 3 months for 2 years, then biannually thereafter.
Participants in the control arm will receive SOC treatment as mentioned above. After 1 year, the investigational treatment will be stopped, and all participants will continue SOC treatment and surveillance.
The enrollment period is expected to be 1 year. The study will be terminated after the final visit of the last patient. The total study duration is expected to be 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥ 18 years.
- •Non-muscle invasive urothelial carcinoma, histologically confirmed by TURBT procedure within 3 months before enrollment.
- •Complete resection of bladder tumor in recent TURBT.
排除标准
- •Inability to provide informed consent.
- •Inability to swallow tablets (esophageal stricture, feeding through gastrostomy).
- •Ineligibility for SOC therapy such as BCG instillations (where appropriate).
- •Upper tract urothelial carcinoma within the past 2 years.
- •Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma).
- •Estimated life expectancy < 5 years.
- •Pregnant women, and women planning future pregnancy or wishing to preserve fertility.
- •Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.
研究组 & 干预措施
LCS103 + Standard of Care
Patients in the investigational arm will receive 1-year bidaily 3 oral tablets of LCS103 herbal formula, in addition to the SOC recommended per risk group
干预措施: LCS103 (Dietary Supplement)
Standard of Care Alone
Participants in the control arm will receive SOC-recommended treatment according to risk group
结局指标
主要结局
LCS103 Safety
时间窗: During the 1-year LCS103 administration period.
Rate and severity of treatment-associated adverse events according to CTCAE v5.0 grading system.
LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0
时间窗: During the 1-year LCS103 administration period.
Incidence and severity of treatment-associated adverse events according to CTCAE v5.0 grading system.
次要结局
- Adherence to the study treatment(During the 1-year study administration period)
- Bladder cancer recurrence at 1 year(During the 1-year study administration period)
- Bladder cancer stage or grade progression at 1 year(Baseline to the end of the 1-year study follow-up period)
- Change in urinary symptom severity (IPSS)(Baseline to the end of the 1-year study follow-up period)
- Change in overall health-related quality of life (EQ-5D-5L/EQ-VAS)(Baseline to the end of the 1-year study follow-up period)
- Change in erectile function - male participants only (IIEF-EF)(Baseline to the end of the 1-year study follow-up period)
- Change in serum C-reactive protein (CRP)(Baseline to the end of the 1-year study follow-up period)
- Change in neutrophil-to-lymphocyte ratio (NLR)(Baseline to the end of the 1-year study follow-up period)
- Change in urinary leucocyte count (leucocyturia)(Baseline to the end of the 1-year study follow-up period)
- Change in tongue appearance - a common measure of inflammation in traditional Chinese medicine.(Baseline to the end of the 1-year study follow-up period)
- Change in maximum urinary flow rate (Qmax) - from uroflowmetry.(Baseline to the end of the 1-year study follow-up period)
- Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count(During the 1-year study administration period)