Bladder Urothelial CarcinomaPhase 4NCT05220124
A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
A Phase 4 study testing Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) in people with Bladder Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma
- What is being tested?
- Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 30 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Hailong Hu, +86-13662096232, hhllove2004@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Urothelial Carcinoma
- Being tested
- Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)
- Keywords
- Immunotherapy, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)Drug
Also called Probiotic
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) |
| Immunotherapy without Probiotics | No intervention | control group, Immunotherapy without Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from randomness to the first occurrence of disease progression or death from any cause.
Measured: up to 3 years
Secondary outcomes (5)
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）.
Measured: 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.
Measured: up to 3 years
Serious Adverse Event (SAE)
The adverse events that occurred in the study were difficult to manage.
Measured: up to 3 years
Overall response rate (ORR)
defined as the proportion of patients who have a partial or complete response to therapy.
Measured: 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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start5 Jan 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Hu, MD,PhD, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220124
- Sponsor's protocol ID
- Truce-03
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Control Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT05220124
- Acronym / sponsor ID
- Truce-03
- Conditions
- Bladder Urothelial Carcinoma
- Keywords
- Immunotherapy, Probiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) | Experimental | Drug: 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. |
| Immunotherapy without Probiotics | No intervention | –control group, Immunotherapy without Probiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)Also: Probiotic420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles. | Drug | Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 3 years
Time from randomness to the first occurrence of disease progression or death from any cause.
5 secondary outcomes
Duration of Response (DOR)
Time frame: up to 3 years
Overall Survival (OS)
Time frame: up to 3 years
Serious Adverse Event (SAE)
Time frame: up to 3 years
Overall response rate (ORR)
Time frame: up to 3 years
Disease control rate (DCR)
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailong Hu, MD,PhD principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) in people with Bladder Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailong Hu, MD,PhD (+86-13662096232, hhllove2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.