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

NCT05220124 | Unknown Phase 4

• 1 other identifier: Truce-03
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Urothelial Carcinoma

Keywords

Immunotherapy; Probiotic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from randomness to the first occurrence of disease progression or death from any cause.

  up to 3 years

Secondary Outcomes (5)

• Duration of Response (DOR)

  up to 3 years

• Overall Survival (OS)

  up to 3 years

• Serious Adverse Event (SAE)

  up to 3 years

• Overall response rate (ORR)

  up to 3 years

• Disease control rate (DCR)

  up to 3 years

Other Outcomes (1)

• 16s rDNA sequencing

  up to 3 years

Study Arms (2)

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

EXPERIMENTAL

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)

Immunotherapy without Probiotics

NO INTERVENTION

control group, Immunotherapy without Probiotics

Interventions

Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) DRUG

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

Also known as: Probiotic

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Interventions

Lacteol; Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hailong Hu, MD,PhD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hailong Hu, MD,PhD

CONTACT

+86-13662096232; hhllove2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 2, 2022
• Study Start: January 5, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

CN (1)