Clinical trial · Interventional
A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
An Open Label, Randomized Control Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
NCT05220124CI-TRIAL-00056285unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
- description
- 420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.
- interventionNames
- Drug: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
- type
- NO_INTERVENTION
- label
- Immunotherapy without Probiotics
- description
- control group, Immunotherapy without Probiotics
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 3 years
- description
- Time from randomness to the first occurrence of disease progression or death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with urothelial carcinoma and undergoing immunotherapy ; 2. Age ≥ 18 years; 3. Expected survival time is greater than 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2; 5. Organ function level must meet the following requirements: Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by symptomatic treatment); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN (can be maintained by symptomatic treatment); 6. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up; 7. Willing and able to provide written informed consent. Exclusion Criteria: 1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period; 2. Active, known or suspected autoimmune diseases; 3. Cannot take orally or are allergic to probiotics ; 4. History of primary immunodeficiency ; 5. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 6. Pregnant or lactating female patients; 7. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; 8. Uncontrolled concurrent diseases, including but not limited to: HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[hypertension greater than or equal to conmon terminology criteria for adverse events (CTCAE) grade 2 after drug treatment\]); Patients with active bleeding or new thrombotic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.