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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGProgression-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
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