A Phase 4 interventional study of Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) in Bladder Urothelial Carcinoma, sponsored by Tianjin Medical University Second Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Tianjin Medical University Second Hospital · Phase 4, Interventional, and Treatment
A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 190 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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);
Exclusion Criteria:
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.
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)
control group, Immunotherapy without Probiotics
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.
Also known as: Probiotic
Progression-free survival (PFS)
Time from randomness to the first occurrence of disease progression or death from any cause.
Time frame: up to 3 years
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）.
Time frame: 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.
Time frame: up to 3 years
Serious Adverse Event (SAE)
The adverse events that occurred in the study were difficult to manage.
Time frame: up to 3 years
Overall response rate (ORR)
defined as the proportion of patients who have a partial or complete response to therapy.
Time frame: 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.
Time frame: up to 3 years
16s rDNA sequencing
Identify the subgroups that are most likely to benefit from intestinal probiotic therapy.
Time frame: up to 3 years
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tianjin Medical University Second Hospital