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LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Rambam Health Care Campus, Urology Department
RECRUITING
Haifa
Contact Information
Primary
Yair Maimon, Dr.
yair@tcm.org.il
+972-3-5043030
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: 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
No_intervention: Standard of Care Alone
Participants in the control arm will receive SOC-recommended treatment according to risk group
Sponsors
Leads: LifeBiotic Medical Research Ltd.

This content was sourced from clinicaltrials.gov

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