Status:
UNKNOWN
A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
Lead Sponsor:
Tianjin Medical University Second Hospital
Conditions:
Bladder Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.
Detailed Description
To evaluate the progression free survival of intestinal probiotics in immunotherapy for urothelial carcinoma. Changes in fecal flora abundance before and after treatment were assessed to identify subj...
Eligibility Criteria
Inclusion
- Patients diagnosed with urothelial carcinoma and undergoing immunotherapy ;
- Age ≥ 18 years;
- Expected survival time is greater than 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2;
- 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);
- The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
- Willing and able to provide written informed consent.
Exclusion
- Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
- Active, known or suspected autoimmune diseases;
- Cannot take orally or are allergic to probiotics ;
- History of primary immunodeficiency ;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating female patients;
- 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;
- 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.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05220124
Start Date
January 5 2022
End Date
November 30 2024
Last Update
February 2 2022
Active Locations (1)
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1
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China, 300211