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

Tianjin Medical University Second Hospital

Status and phase

Enrolling

Phase 4

Conditions

Bladder Urothelial Carcinoma

Treatments

Drug: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

Study type

Interventional

Funder types

Other

Identifiers

NCT05220124

Truce-03

Details and patient eligibility

About

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

Full 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 subjects most likely to benefit from enteric probiotics treatment.

Enrollment

190 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.