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
Qualifiers
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
Treatments tested in this trial
- Probiotics Compound (Biolosion)
- Nab-paclitaxel
- Cisplatin
- Gemcitabine
- Disitamab vedotin
- Enfortumab Vedotin
- Pembrolizumab
- Toripalimab
Treatment groups
222 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov