Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06904573

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

Led by Sun Yat-sen University · Updated on 2025-04-01

222

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

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 physician's 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.

CONDITIONS

Brief Title

Probiotics in Advanced Urothelial Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 or above
  • Confirmed locally advanced inoperable or metastatic urothelial carcinoma including bladder, ureter, renal pelvis, or urethra
  • Previous treatment with immune checkpoint inhibitors allowed
  • At least one measurable target lesion according to RECIST1.1
  • ECOG performance status score of 2 or less
  • Good bone marrow, kidney (creatinine clearance > 30 mL/min), liver, and coagulation function
  • Expected survival of at least 6 months
  • Understands study procedures and provides written informed consent
  • Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose
  • Use of highly effective contraception for both male and female participants if pregnancy risk exists, continued for 180 days after treatment
Not Eligible

You will not qualify if you...

  • Candidates for local radical treatment for locally advanced disease
  • History of symptomatic cardiovascular, liver, respiratory, renal, hematoendocrine, or neuropsychiatric diseases
  • Known brain or meningeal metastasis
  • Peripheral neuropathy greater than grade 1
  • Recent anti-tumor monoclonal antibody or other anti-tumor treatments within 4 weeks without recovery from side effects
  • Participation in another investigational drug treatment within 4 weeks
  • Recent axial bone radiotherapy within 4 weeks without recovery
  • Known severe allergy to study drugs or ingredients
  • Immunodeficiency or use of systemic immunosuppressive therapy within 7 days before first dose (physiological doses allowed)
  • Active autoimmune diseases requiring systemic treatment within 2 years before first dose
  • History of solid organ or blood system transplantation
  • Known HIV infection or untreated active hepatitis B
  • Active hepatitis C infection or recent live vaccine within 30 days before first dose
  • History of other malignancies within 5 years except certain cured or low-risk cancers
  • Any medical conditions interfering with study participation
  • Breastfeeding women
  • Chronic diseases requiring long-term antibiotic use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 48 months or until disease progression or discontinuation

Participants receive oral probiotics compound plus immune checkpoint inhibitors-based therapies, or immune checkpoint inhibitors-based therapies alone, with various chemotherapy agents administered intravenously according to the investigator's choice.

Regular intravenous treatments every 1 to 3 weeks depending on regimen

Follow-up

Duration - Up to approximately 48 months

Participants are monitored after treatment ends to assess progression-free survival, overall survival, and treatment-related outcomes.

Periodic follow-up visits as determined by the study team

Trial Site Locations

Total: 3 locations

1

Sun yat-sen university cancer center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Not Yet Recruiting

3

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

Wuhan, Hubei, China

Not Yet Recruiting

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Research Team

Y

Yanxia Shi, Doctor

H

Haifeng Li, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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