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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients included in this study must meet all of the following criteria:

‣ 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;

⁃ ECOG score ≤2;

⁃ Good bone marrow, kidney (serum creatinine clearance calculated by CG formula\> 30 mL/min), liver and coagulation function:

⁃ Expected survival period ≥ 6 months;

⁃ The patient understands the research procedures and signs the informed consent form in writing to indicate his/her agreement to participate in the study;

⁃ Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days before the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.

‣ If there is a risk of pregnancy, male and female patients should use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue for at least 180 days after stopping the trial treatment.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
Sun yat-sen university cancer center
RECRUITING
Guangzhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Yanxia Shi, Doctor
shiyx@sysucc.org.cn
86-020-87343486
Backup
Haifeng Li, Doctor
lihf@sysucc.org.cn
86-020-87343486
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 222
Treatments
Experimental: Experiment group
Subjects in this arm will receive an oral probiotics compound (Biolosion) plus the Investigator's choice of immune checkpoint inhibitor-based (ICIs-based) therapies:~Regimens that combine with chemotherapy agents can include but are not limited to Nab-paclitaxel, Cisplatin, Gemcitabine, Disitamab vedotin, Enfortumab Vedotin; Immune checkpoint inhibitors include but are not limited to Pembrolizumab and toripalimab.
Active_comparator: Control group
Subjects in this arm will receive Investigator's choice of immune checkpoint inhibitors-based (ICIs-based) therapies
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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