Probiotics in Advanced Urothelial Carcinoma

NCT06904573 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-FXY-297
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Urothelial Carcinoma; Probiotics; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-Free Survival (PFS) is defined as the time from randomization to the first documented disease progression, as determined by RECIST v1.1, or death from any cause, whichever occurs first. Disease progression will be assessed by independent radiologic review. Patients without documented progression or death at the time of analysis will be censored at their last tumor assessment date.

  Within approximately 48 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Within approximately 48 months

• Objective Response Rate (ORR)

  Within approximately 48 months

• Disease Control Rate (DCR)

  Within approximately 48 months

• Time to Response (TTR)

  Within approximately 48 months

• Duration of Response (DOR)

  Within approximately 48 months

Other Outcomes (1)

• Analysis of the microbiota

  Baseline, through study completion, an average of 48 months

Study Arms (2)

Experiment group

EXPERIMENTAL

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.

Drug: Probiotics Compound (Biolosion); Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: Gemcitabine; Drug: Disitamab vedotin; Drug: Enfortumab Vedotin; Drug: Pembrolizumab; Drug: Toripalimab

Control group

ACTIVE COMPARATOR

Subjects in this arm will receive Investigator's choice of immune checkpoint inhibitors-based (ICIs-based) therapies

Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: Gemcitabine; Drug: Disitamab vedotin; Drug: Enfortumab Vedotin; Drug: Pembrolizumab; Drug: Toripalimab

Interventions

Probiotics Compound (Biolosion) DRUG

15g, PO, qd

Experiment group

Nab-paclitaxel DRUG

230mg/m2, IV, days 1, 8, q3w

Control group; Experiment group

Cisplatin DRUG

70mg/m2, IV, days 1-3, q3w

Control group; Experiment group

Gemcitabine DRUG

1.2g/m2, IV, days 1, 8, q3w

Control group; Experiment group

Disitamab vedotin DRUG

2.5mg/kg, IV, q2w

Control group; Experiment group

Enfortumab Vedotin DRUG

1.25mg/kg, IV, days 1, 8, q3w

Control group; Experiment group

Pembrolizumab DRUG

200mg, IV, q3w

Control group; Experiment group

Toripalimab DRUG

240mg, IV, q3w

Control group; Experiment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with locally advanced disease may receive local radical treatment;
• History of clinically symptomatic cardiovascular, liver, respiratory, renal, hematoendocrine, or neuropsychiatric diseases;
• Clear brain/meningeal metastasis;
• Peripheral neuropathy \>1 degree;
• Patients who have received anti-tumor monoclonal antibody treatment within 4 weeks before the start of the study, or have received other anti-tumor drug treatment and have not recovered from adverse events/reactions;
• Participated in any investigational drug treatment within 4 weeks before the start of treatment;
• Patients who had received axial bone radiotherapy within 4 weeks before the start of the study or had not recovered from adverse reactions caused by previous radiotherapy;
• Known severe allergic reaction to the study drug, its active ingredients and/or any excipients;
• Patients diagnosed with immunodeficiency or receiving systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days before the first dose of the study; physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent drugs) are allowed;
• Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose or current interstitial lung disease;
• Received solid organ or blood system transplantation;
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive). Untreated active hepatitis B;
• Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit) received live vaccine within 30 days before the first dose (Cycle 1, Day 1);
• A history of other malignant tumors in the past 5 years, excluding cured non-malignant melanoma of the skin, cervical carcinoma in situ, and incidentally discovered prostate cancer (stage lower than T2N0M0, Gleason score \<7, or undetectable PSA);
• Medical history or disease evidence, abnormal treatment or laboratory test values, or other conditions that the researcher considers unsuitable for enrollment that may interfere with the trial results or prevent the subject from fully participating in the study;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (3)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

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

Wuhan, Hubei, China

NOT YET RECRUITING

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MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Gemcitabine; disitamab vedotin; enfortumab vedotin; pembrolizumab; toripalimab

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yanxia Shi, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Shi, Doctor

CONTACT

86-020-87343486; shiyx@sysucc.org.cn

Haifeng Li, Doctor

CONTACT

86-020-87343486; lihf@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: April 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)