Clinical trial NCT05220124: A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
Official title: An Open Label, Randomized Control Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bladder Urothelial Carcinoma
Keywords: Immunotherapy
Probiotic
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 subjects most likely to benefit from enteric probiotics treatment.

Eligibility 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: up to 3 years
measure: Overall Survival (OS)
timeFrame: up to 3 years
measure: Serious Adverse Event (SAE)
timeFrame: up to 3 years
measure: Overall response rate (ORR)
timeFrame: up to 3 years
measure: Disease control rate (DCR)
timeFrame: up to 3 years
Other outcomes:
measure: 16s rDNA sequencing
timeFrame: up to 3 years
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Second Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Hailong Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: