Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Pa… (NCT07474064) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC
China146 participantsStarted 2026-03-26
Plain-language summary
The goal of this clinical trial is to learn if oral probiotics (Clostridium butyricum) work to improve the efficacy of targeted therapy plus immunotherapy in bladder preservation setting for cisplatin-ineligible T2-3N0M0 bladder cancer patients with low serum butyrate.
The main questions it aims to answer are: Do oral probiotics elevate serum butyrate levels and enhance the duation of bladder preservation interval with targeted therapy plus immunotherapy? Researchers will compare oral probiotics combined with targeted therapy plus immunotherapy to standard regimens (targeted therapy plus immunotherapy) to see if oral probiotics can improve its efficacy.
Participants will:
1. Take oral probiotics and/or Disitamab Vedotin (HER2-ADC) and Toripalimab (PD-L1 inhibitor) for one year in total, which is divided into induction treatment period, intensive treatment period and maintenance treatment period.
2. Return to the hospital for evaluation of tumor residual burden according to the follow-up plan, which will include urine cytology, imaging, surgical biopsy, and urine DNA methylation detection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients have histologically confirmed, radiologically staged cT2-3N0M0 urothelial carcinoma of the bladder, in which urothelial carcinoma is the predominant component (\>50%).
* Serum butyrate level \<46 μg/L as determined by quantitative mass spectrometry.
* HER2 expression is assessed by immunohistochemistry (IHC) on pretreatment tumor specimens, with confirmed IHC ≥1+.
* Patients are deemed ineligible for radical cystectomy based on laboratory evaluation and patient preference.
* Patients considered ineligible for cisplatin therapy and meeting at least one of the following criteria: ECOG performance status \>1 or Karnofsky performance status of 60-70%; Creatinine clearance \<60 mL/min; Hearing loss ≥ Grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0; Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE v5.0); New York Heart Association (NYHA) Class III or higher heart failure.
* ECOG performance status of 0-2.
* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.
Exclusion Criteria:
* Prior ADCs or PD-1/PD-L1 inhibitor therapy.
* Known hypersensitivity to microbiota-related preparations (microecological products), RC48-ADC or Toripalimab or any of its components.
* Receipt of other approved systemic anticancer therapy or systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, and tumour necrosis factor) within 28 days prior to enro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
bladder-intact event free survival (BI-EFS), evaluated by independent review committee