Actively Recruiting
Probiotics in Advanced Urothelial Carcinoma
Led by Sun Yat-sen University · Updated on 2025-04-01
222
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotics in Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or above
- Histologically or cytologically confirmed locally advanced inoperable or metastatic urothelial carcinoma
- Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 antibodies) allowed
- At least one measurable target lesion by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Good bone marrow, kidney (creatinine clearance > 30 mL/min), liver, and coagulation function
- Expected survival of 6 months or more
- Able to understand study procedures and provide written informed consent
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Use of highly effective contraception during study and for 180 days after stopping treatment if at risk of pregnancy
You will not qualify if you...
- Locally advanced disease patients eligible for local radical treatment
- History of symptomatic cardiovascular, liver, respiratory, kidney, endocrine, or neuropsychiatric diseases
- Presence of brain or meningeal metastasis
- Peripheral neuropathy greater than grade 1
- Received anti-tumor monoclonal antibody treatment within 4 weeks before study start
- Received other anti-tumor drug treatment with unresolved side effects
- Participation in any investigational drug treatment within 4 weeks before study
- Axial bone radiotherapy within 4 weeks before study or unresolved side effects from prior radiotherapy
- Known severe allergy to study drug or its ingredients
- Diagnosed immunodeficiency or systemic immunosuppressive therapy within 7 days before first dose
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
- History of non-infectious pneumonia requiring glucocorticoids within 1 year or current interstitial lung disease
- Received solid organ or blood system transplantation
- Known HIV infection or untreated active hepatitis B
- Active hepatitis C infection or received live vaccine within 30 days before first dose
- History of other cancers within past 5 years except certain cured or low-risk types
- Medical conditions or abnormal tests that may interfere with study or participation
- Breastfeeding women
- Chronic diseases requiring long-term antibiotic use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Not Yet Recruiting
Research Team
Y
Yanxia Shi, Doctor
CONTACT
H
Haifeng Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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