LCS103 Herbal Formula for Preventing NMIBC Recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIa, single-site, randomized, open-label trial will enroll 60 adults with non-muscle invasive urothelial carcinoma of the bladder who recently had TURBT. Participants are randomized 1:1 to receive LCS103 plus standard care (SOC) or SOC alone for one year. The LCS103 group takes three tablets twice daily and follows risk-stratified SOC monitoring, with procedures such as cystoscopy and intravesical therapies (BCG) as indicated by risk level. After one year, LCS103 is stopped, and all participants continue SOC monitoring as needed. The study aims to assess safety and see if adding LCS103 can reduce recurrence or progression compared with SOC alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rambam Health Care Campus, Urology Department
  Haifa, Israel Recruiting

Study contacts

• Principal investigator: Etan Eigner, MD — Rambam Health Care Campus
• Study coordinator: Yair Maimon, Dr.
• Email: yair@tcm.org.il
• Phone: +972-3-5043030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.