Overview

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

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.