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LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder

RecruitingNAAges 18 Years - anyAllLifeBiotic Medical Research Ltd.
NCT07728474 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • LCS103
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Where

1 site
Rambam Health Care Campus, Urology Department
Haifa, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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