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

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

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.

Conditions2

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