Probiotics in Advanced Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or above;
Histologically or cytologically confirmed locally advanced inoperable (such as T4b, or N2-3) or metastatic urothelial carcinoma, including bladder, ureter, renal pelvis and urethra;
Patients who have received previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) are allowed;
According to RECIST1.1 standard, there is at least one measurable target lesion;
Disqualifiers
Patients with locally advanced disease may receive local radical treatment;
History of clinically symptomatic cardiovascular, liver, respiratory, renal, hematoendocrine, or neuropsychiatric diseases;
Clear brain/meningeal metastasis;
Peripheral neuropathy >1 degree;
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotics Compound (Biolosion)
Drug15g, PO, qd
Nab-paclitaxel
Drug230mg/m2, IV, days 1, 8, q3w
Cisplatin
Drug70mg/m2, IV, days 1-3, q3w
Gemcitabine
Drug1.2g/m2, IV, days 1, 8, q3w
Disitamab vedotin
Drug2.5mg/kg, IV, q2w
Enfortumab Vedotin
Drug1.25mg/kg, IV, days 1, 8, q3w
Pembrolizumab
Drug200mg, IV, q3w
Toripalimab
Drug240mg, IV, q3w
Treatment groups
222 Participants
are divided into 2 treatment groupsGroup A: Experiment groupExperimental treatment 8 interventions
Group B: Control groupActive comparator 7 interventions
Trial outcomes
Primary outcomes
1
Progression-free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization to the first documented disease progression, as determined by RECIST v1.1, or death from any cause, whichever occurs first. Disease progression will be assessed by independent radiologic review. Patients without documented progression or death at the time of analysis will be censored at their last tumor assessment date.
Time frame
Within approximately 48 monthsSecondary outcomes
1
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. Participants still alive at the time of analysis will be censored at the date of the last follow-up.
Time frame
Within approximately 48 months2
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria, based on radiologic assessment. Responses will be confirmed by at least one subsequent imaging assessment.
Time frame
Within approximately 48 months3
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) for at least 6 weeks after treatment initiation, based on RECIST v1.1 criteria.
Time frame
Within approximately 48 months4
Time to Response (TTR)
Time to Response (TTR) is defined as the time from randomization to the first occurrence of a confirmed objective response (CR or PR) as determined by RECIST v1.1 criteria.
Time frame
Within approximately 48 monthsOther outcomes
1
Analysis of the microbiota
The stool samples of participants before and after treatment were collected and analyzed by 16S rRNA and were used to investigate the changes in the diversity of microbiota.
Time frame
Baseline, through study completion, an average of 48 monthsSponsors and contacts
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Source ClinicalTrials.gov