NCT06904573

Probiotics in Advanced Urothelial Carcinoma

A Multicenter, Randomized Controlled Phase II Study of Evaluating the Efficacy and Safety of Immunotherapy Combined With Oral Probiotics Compound (Biolosion) in Patients With Advanced Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This multicenter, randomized phase II trial is designed to study the efficacy and safety of probiotics compound (Biolosion) Immunotherapy of the physician's choice (IPC) plus versus IPC in patients with advanced urothelial carcinoma (aUC). Pervious received platinum-based therapies, previous received Immune checkpoint inhibitors, and the treatment lines will stratify randomization.

Conditions

• Advanced Urothelial Carcinoma
• Probiotics
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Probiotics Compound (Biolosion)	15g, PO, qd
DRUG	Nab-paclitaxel	230mg/m2, IV, days 1, 8, q3w
DRUG	Cisplatin	70mg/m2, IV, days 1-3, q3w
DRUG	Gemcitabine	1.2g/m2, IV, days 1, 8, q3w
DRUG	Disitamab vedotin	2.5mg/kg, IV, q2w
DRUG	Enfortumab Vedotin	1.25mg/kg, IV, days 1, 8, q3w
DRUG	Pembrolizumab	200mg, IV, q3w
DRUG	Toripalimab	240mg, IV, q3w

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

3 sites across 1 country: China