Health Trials

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 groups

Locations

3
Sun Yat-sen Memorial Hospital GuangzhouGuangdong, China
Sun yat-sen university cancer center510000, GuangzhouGuangdong, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology WuhanHubei, China

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov