NCT07728474Recruiting
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- LifeBiotic Medical Research Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT07728474
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jul 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ineligibility for SOC therapy such as BCG instillations (where appropriate).
Other illness
- Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma).
- Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.
Age
- Estimated life expectancy \< 5 years.
Other
- Inability to provide informed consent.
- Inability to swallow tablets (esophageal stricture, feeding through gastrostomy).
- Upper tract urothelial carcinoma within the past 2 years.
- Pregnant women, and women planning future pregnancy or wishing to preserve fertility.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus, Urology Department Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.