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

Primary Purpose

Bladder Urothelial Carcinoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Urothelial Carcinoma focused on measuring Immunotherapy, Probiotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Medical University Second HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

Immunotherapy without Probiotics

Arm Description

420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.

control group, Immunotherapy without Probiotics

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Time from randomness to the first occurrence of disease progression or death from any cause.

Secondary Outcome Measures

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).
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.
Serious Adverse Event (SAE)
The adverse events that occurred in the study were difficult to manage.
Overall response rate (ORR)
defined as the proportion of patients who have a partial or complete response to therapy.
Disease control rate (DCR)
The percentage of cases with remission and lesion stability after treatment in the number of evaluable cases.

Full Information

First Posted
January 14, 2022
Last Updated
February 1, 2022
Sponsor
Tianjin Medical University Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05220124
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Urothelial Carcinoma
Keywords
Immunotherapy, Probiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
Arm Type
Experimental
Arm Description
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.
Arm Title
Immunotherapy without Probiotics
Arm Type
No Intervention
Arm Description
control group, Immunotherapy without Probiotics
Intervention Type
Drug
Intervention Name(s)
Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
Other Intervention Name(s)
Probiotic
Intervention Description
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Time from randomness to the first occurrence of disease progression or death from any cause.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
The time from the first judgment of complete response (CR) or partial response (PR) to the discovery of progressive disease (PD).
Time Frame
up to 3 years
Title
Overall Survival (OS)
Description
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.
Time Frame
up to 3 years
Title
Serious Adverse Event (SAE)
Description
The adverse events that occurred in the study were difficult to manage.
Time Frame
up to 3 years
Title
Overall response rate (ORR)
Description
defined as the proportion of patients who have a partial or complete response to therapy.
Time Frame
up to 3 years
Title
Disease control rate (DCR)
Description
The percentage of cases with remission and lesion stability after treatment in the number of evaluable cases.
Time Frame
up to 3 years
Other Pre-specified Outcome Measures:
Title
16s rDNA sequencing
Description
Identify the subgroups that are most likely to benefit from intestinal probiotic therapy.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hailong Hu, MD,PhD
Phone
+86-13662096232
Email
hhllove2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailong Hu, MD,PhD
Organizational Affiliation
Tianjin Medical University Second Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Second Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailong Hu
Phone
+86-13662096232
Email
hhllove2004@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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