Phase II Study of Immunotherapy With Oral Probiotics Biolosion in Adults With Advanced Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining immunotherapy with an oral probiotics compound called Biolosion in patients with advanced urothelial carcinoma, a type of cancer affecting the bladder and urinary tract. This phase II multicenter randomized trial includes patients who have previously received platinum-based chemotherapy and immune checkpoint inhibitors, aiming to understand how these treatments work together in this advanced cancer setting. Participants will be randomly assigned to one of two groups. One group will receive the probiotics Biolosion daily along with the physicians choice of immune checkpoint inhibitor-based therapies, which may include chemotherapy agents such as Nab-paclitaxel, Cisplatin, Gemcitabine, or targeted drugs like Disitamab vedotin and Enfortumab Vedotin, or immune checkpoint inhibitors like Pembrolizumab and Toripalimab. The other group will receive only the immune checkpoint inhibitor-based therapies chosen by the physician. Treatment schedules vary depending on the specific drugs used, including intravenous infusions on set days and daily oral probiotics. During the study, participants will undergo regular assessments to monitor their response to treatment, including measuring progression-free survival over approximately 48 months. Researchers will also evaluate overall survival, tumor response rates, disease control, time to response, duration of response, and treatment-related side effects. Participants will be closely monitored for safety and may provide informed consent before joining. The study aims to last several years, with ongoing evaluations to understand the impact of adding probiotics to immunotherapy in advanced urothelial carcinoma.

Probiotics in Advanced Urothelial Carcinoma