A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
- Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone?
- Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
- Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone.
- Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group.
- Hold the liquid in the bladder for up to 2 hours during each visit.
- Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue.
- Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns.
- Fill out questionnaires about their quality of life.
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
- 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
- •Signed and dated informed consent.
- •Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
- •Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
- •Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
- •Primary multifocal (<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
- •Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
- •Recurrent multifocal (<10 lesions), Ta, low-grade, >1 year after previous recurrence.
- •Men and women aged 18 years or older.
- •Negative pregnancy test at screening for women of childbearing potential.
- •Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study.
- •Ability to retain bladder contents for 2 hours.
排除标准
- •Patient with non-papillary tumor appearance at the time of initial cystoscopy.
- •Previous history of T1 or high-grade disease in recurrent tumors.
- •Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- •Previous intravesical BCG immunotherapy.
- •Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
- •Acute urinary tract infection requiring antibiotic treatment.
- •Prior radiotherapy or systemic chemotherapy.
- •WHO performance status of 3 or
- •Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- •Known active HIV infection, defined as detectable HIV viral load at screening.
- •Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
- •Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
- •Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
- •Previously enrolled in this trial.
研究组 & 干预措施
Alpha1H
Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT).
干预措施: Transurethral Resection of Bladder Tumor (TURBT) (Procedure)
Standard of Care
Participants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy.
干预措施: Transurethral Resection of Bladder Tumor (TURBT) (Procedure)
Standard of Care
Participants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy.
干预措施: Intravesical Chemotherapy (Drug)
Alpha1H
Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT).
干预措施: Intravesical Chemotherapy (Drug)
Alpha1H
Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT).
干预措施: Alpha1H (Drug)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
次要结局
- Complete Response (CR) Rate(Day 30 (±5 days), prior to TURBT)
- Overall Survival (OS)(From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).)
- Tumor Response (Morphological and Cellular)(Baseline (Day 1) to Day 30 (±5 days))
- Tumor Gene Expression(Baseline (Day 1) to Day 30 (±5 days))
- Urinary Biomarkers and Immune Response(Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days))
- Incidence and Severity of Adverse Events (AEs)(From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years))
- Change in Quality of Life (QoL) as Assessed by the QLQ-NMIBC24 Questionnaire(From Visit 1 (Screening) through follow-up visits (up to 3 years))