A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma

• Status: Recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Second Hospital

Criteria

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.