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

Bladder Urothelial Carcinoma Clinical Trial

Official title:

An Open Label, Randomized Control Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220124
• Other study ID #: Truce-03
• Status: Recruiting
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2022
• Source: Tianjin Medical University Second Hospital
• Contact: Hailong Hu, MD,PhD
• Phone: +86-13662096232
• Email: hhllove2004[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Urothelial Carcinoma
• Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.

Locations

Country	Name	City	State
China	Tianjin Medical University Second Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	16s rDNA sequencing	Identify the subgroups that are most likely to benefit from intestinal probiotic therapy.	up to 3 years
Primary	Progression-free survival (PFS)	Time from randomness to the first occurrence of disease progression or death from any cause.	up to 3 years
Secondary	Duration of Response (DOR)	The time from the first judgment of complete response (CR) or partial response (PR) to the discovery of progressive disease (PD).	up to 3 years
Secondary	Overall Survival (OS)	Defined as the number of days from study entry to death. Individuals who are alive at last contact will be censored on the date of last contact.	up to 3 years
Secondary	Serious Adverse Event (SAE)	The adverse events that occurred in the study were difficult to manage.	up to 3 years
Secondary	Overall response rate (ORR)	defined as the proportion of patients who have a partial or complete response to therapy.	up to 3 years
Secondary	Disease control rate (DCR)	The percentage of cases with remission and lesion stability after treatment in the number of evaluable cases.	up to 3 years