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Probiotics in Advanced Urothelial Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Probiotics in Advanced Urothelial Carcinoma

A Multicenter, Randomized Controlled Phase II Study of Evaluating the Efficacy and Safety of Immunotherapy Combined With Oral Probiotics Compound (Biolosion) in Patients With Advanced Urothelial Carcinoma

NCT06904573•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.

Detailed Description

This multicenter, randomized phase II trial is designed to study the efficacy and safety of probiotics compound (Biolosion) Immunotherapy of the physician's choice (IPC) plus versus IPC in patients with advanced urothelial carcinoma (aUC). Pervious received platinum-based therapies, previous received Immune checkpoint inhibitors, and the treatment lines will stratify randomization.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients included in this study must meet all of the following criteria:
•1. Aged 18 or above;
•2. Histologically or cytologically confirmed locally advanced inoperable (such as T4b, or N2-3) or metastatic urothelial carcinoma, including bladder, ureter, renal pelvis and urethra;
•3. Patients who have received previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) are allowed;
•4. According to RECIST1.1 standard, there is at least one measurable target lesion;
•5. ECOG score ≤2;
•6. Good bone marrow, kidney (serum creatinine clearance calculated by CG formula\> 30 mL/min), liver and coagulation function:
•7. Expected survival period ≥ 6 months;
•8. The patient understands the research procedures and signs the informed consent form in writing to indicate his/her agreement to participate in the study;
•9. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days before the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.
+1 more criteria

Exclusion Criteria

•1. Patients with locally advanced disease may receive local radical treatment;
•2. History of clinically symptomatic cardiovascular, liver, respiratory, renal, hematoendocrine, or neuropsychiatric diseases;
•3. Clear brain/meningeal metastasis;
•4. Peripheral neuropathy \>1 degree;
•5. Patients who have received anti-tumor monoclonal antibody treatment within 4 weeks before the start of the study, or have received other anti-tumor drug treatment and have not recovered from adverse events/reactions;
•6. Participated in any investigational drug treatment within 4 weeks before the start of treatment;
•7. Patients who had received axial bone radiotherapy within 4 weeks before the start of the study or had not recovered from adverse reactions caused by previous radiotherapy;
•8. Known severe allergic reaction to the study drug, its active ingredients and/or any excipients;
•9. Patients diagnosed with immunodeficiency or receiving systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days before the first dose of the study; physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent drugs) are allowed;
•10. Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose or current interstitial lung disease;
+8 more criteria

Locations (3)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Key Dates

Start Date

January 1, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2028

Last Updated

April 1, 2025

Enrollment

222

ESTIMATED participants

Conditions

Advanced Urothelial CarcinomaProbioticsImmunotherapy

Interventions

Probiotics Compound (Biolosion)

DRUG

Nab-paclitaxel

DRUG

Cisplatin

DRUG

Gemcitabine

DRUG

Disitamab vedotin

DRUG

Enfortumab Vedotin

DRUG

Pembrolizumab

DRUG

Toripalimab

DRUG

Contacts

Yanxia Shi, Doctor

CONTACT

86-020-87343486 shiyx@sysucc.org.cn

Haifeng Li, Doctor

CONTACT

86-020-87343486 lihf@sysucc.org.cn

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy

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A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

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Advanced Urothelial CarcinomaOral Drug Administration+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Probiotics in Advanced Urothelial Carcinoma

Inclusion Criteria

Exclusion Criteria

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy

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