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RECRUITING
NCT06904573
PHASE2

Probiotics in Advanced Urothelial Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2025-01-01

Completion Date

2028-01-01

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

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

Locations (3)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China