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

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

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

Study Overview

• Status: Recruiting
• Conditions: Bladder Urothelial Carcinoma
• Intervention / Treatment: Drug: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hailong Hu, MD,PhD; Phone Number: +86-13662096232; Email: hhllove2004@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300211
      • Recruiting
      • Tianjin Medical University Second Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules); 420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.	Drug: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules); 420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.; Other Names: Probiotic
No Intervention: Immunotherapy without Probiotics; control group, Immunotherapy without Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Time from randomness to the first occurrence of disease progression or death from any cause.	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Serious Adverse Event (SAE)	The adverse events that occurred in the study were difficult to manage.	up to 3 years
Overall response rate (ORR)	defined as the proportion of patients who have a partial or complete response to therapy.	up to 3 years
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
16s rDNA sequencing	Identify the subgroups that are most likely to benefit from intestinal probiotic therapy.	up to 3 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Second Hospital
• Investigators: Principal Investigator: Hailong Hu, MD,PhD, Tianjin Medical University Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Immunotherapy; Probiotic
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Carcinoma; Urinary Bladder Neoplasms
• Other Study ID Numbers: Truce-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No