Muscle Invasive Bladder Cancer (MIBC)Phase 2NCT07474064
Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC
A Phase 2 study testing Probiotic, Disitamab Vedotin and Toripalimab in people with Muscle Invasive Bladder Cancer (MIBC), run by chenxu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer (MIBC)
- What is being tested?
- Probiotic, Disitamab Vedotin and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2026to 31 Mar 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 enrolment.
- Prior radiotherapy for bladder cancer.
- Prior antitumour drug therapy, except for the following: a. For patients who previously received systemic chemotherapy, a treatment-free interval of at least 3 months between the last dose and the start of induction therapy is required; b. Local intravesical chemotherapy or immunotherapy (including BCG) must be completed at least 1 week before initiation of study neoadjuvant treatment.
- Surgery or significant trauma within 28 days prior to enrolment (implantation of vascular access devices and TURBT are not considered).
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- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrolment.
- Receipt of live vaccines within 28 days prior to enrolment.
- Active autoimmune disease requiring systemic treatment and considered by the investigator to potentially interfere with the study treatment.
- Requirement for long-term high-dose corticosteroids or other immunosuppressive agents.
- Clinically significant abnormalities that may affect treatment, including electrolyte disturbances, hypoalbuminaemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases. These include uncontrolled diabetes, hypertension, or cardiovascular disease, such as active cardiac conditions within 6 months prior to enrolment.
- Untreated chronic hepatitis B with HBV DNA ≥500 IU/mL (2,500 copies/mL) or known HBV carriers with active disease.
- Active hepatitis C infection.
- History of immunodeficiency, including positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency disorders, or a history of allogeneic stem cell transplantation or solid organ transplantation.
- Toxicities from prior therapies that have not recovered to baseline or stabilised.
- Presence of other concomitant malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Li Yan, +86-020-81332587, sysyxllwyh@163.com
Xu Chen, PhD, MD
About this study
Official title: A Multicenter Randomized Controlled Study to Evaluate the Efficacy of Oral Probiotics Combined With PD-1 Monoclonal Antibody and Disitamab Vedotin in Bladder-Preserving Setting for Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer and Low Serum Butyrate
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.
Read more
Participants will:
- 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.
- 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.
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Being tested
- Probiotic, Disitamab Vedotin, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Also called Clostridium butyricum CBM 588 Probiotic Strain
80 mg orally twice daily during induction and intensive treatment periods; 80 mg orally twice daily, 3 weeks on / 3 weeks off dosing schedule during maintenance treatment period
Disitamab VedotinDrug
Also called RC48-ADC
2.0 mg/kg IV every 2 weeks during the induction treatment period and intensive treatment period
ToripalimabDrug
Also called JS001
3.0 mg/kg IV every 2 weeks during the induction and intensive treatment periods; followed by 240 mg IV every 3 weeks during the maintenance treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic + Disitamab Vedotin + Toripalimab | Experimental | Participants will receive oral Clostridium butyricum viable tablets, disitamab vedotin, and toripalimab for about 1 year, or until investigator-assessed bladder preservation failure, loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: Probiotic; Drug: Disitamab Vedotin; Drug: Toripalimab |
| Disitamab Vedotin + Toripalimab | Active comparator | Participants will receive disitamab vedotin and toripalimab for about 1 year, or until investigator-assessed bladder preservation failure, loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: Disitamab Vedotin; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder-intact event free survival (BI-EFS), evaluated by independent review committee
Bladder intact event-free survival (BIEFS) refers to the time from the date of randomization to the first occurrence of any bladder preservation failure event through tumor control, whichever occurs first. Bladder preservation failure events include: 1. Rapid progression: progressive disease (PD) assessed by imaging at the mid-induction evaluation; 2. Tumor recurrence: ≥T2 stage, high-grade urothelial carcinoma (per the WHO 2016 Classification of Tumours of the Urinary System), or non-urothelial carcinoma histology; 3. Tumor metastasis: including lymph node metastasis and distant organ metastasis; 4. Death from any cause; 5. Receipt of radical cystectomy for any other reason.
Measured: Up to approximately 3 years
Secondary outcomes (3)
clinical complete response (cCR)
Clinical complete response rate (cCR) refers to the proportion of participants who achieve all of the following criteria after completion of induction treatment: first, negative urine cytology; second, no new lymph node metastasis or distant metastatic lesions identified on imaging examinations; third, no malignant tumor identified on cystoscopy biopsy, or only low-grade Ta/T1 urothelial carcinoma present.
Measured: Up to approximately 3 years
Metastasis-free survival (MFS)
Metastasis-free survival (MFS) refers to the time from the date of randomization to the first occurrence of lymph node metastasis or distant organ metastasis, whichever occurs first.
Measured: Up to approximately 3 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start26 Mar 2026 (estimated)
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- chenxu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, chenxu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474064
- Sponsor's protocol ID
- PTI-BPS-2026-IIT
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to qualified researchers, along with the study protocol and statistical analysis plan (SAP), after the publication of primary study results. Requests will be reviewed by the study sponsor and steering committee. Data will be shared via a secure, password-protected research data repository for non-commercial, scientific purposes only, in compliance with applicable regulations and ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study to Evaluate the Efficacy of Oral Probiotics Combined With PD-1 Monoclonal Antibody and Disitamab Vedotin in Bladder-Preserving Setting for Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer and Low Serum Butyrate
- ClinicalTrials.gov ID
- NCT07474064
- Acronym / sponsor ID
- PTI-BPS-2026-IIT
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- chenxuUniversity, hospital or other
- Study start
- 26 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic + Disitamab Vedotin + Toripalimab | Experimental | Drug: Probiotic, Drug: Disitamab Vedotin, Drug: ToripalimabParticipants will receive oral Clostridium butyricum viable tablets, disitamab vedotin, and toripalimab for about 1 year, or until investigator-assessed bladder preservation failure, loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| Disitamab Vedotin + Toripalimab | Active comparator | Drug: Disitamab Vedotin, Drug: ToripalimabParticipants will receive disitamab vedotin and toripalimab for about 1 year, or until investigator-assessed bladder preservation failure, loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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 enrolment.
- Prior radiotherapy for bladder cancer.
- Prior antitumour drug therapy, except for the following: a. For patients who previously received systemic chemotherapy, a treatment-free interval of at least 3 months between the last dose and the start of induction therapy is required; b. Local intravesical chemotherapy or immunotherapy (including BCG) must be completed at least 1 week before initiation of study neoadjuvant treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Clostridium butyricum CBM 588 Probiotic Strain80 mg orally twice daily during induction and intensive treatment periods; 80 mg orally twice daily, 3 weeks on / 3 weeks off dosing schedule during maintenance treatment period | Drug | Probiotic + Disitamab Vedotin + Toripalimab |
| Disitamab VedotinAlso: RC48-ADC2.0 mg/kg IV every 2 weeks during the induction treatment period and intensive treatment period | Drug | Disitamab Vedotin + Toripalimab, Probiotic + Disitamab Vedotin + Toripalimab |
| ToripalimabAlso: JS0013.0 mg/kg IV every 2 weeks during the induction and intensive treatment periods; followed by 240 mg IV every 3 weeks during the maintenance treatment period. | Drug | Disitamab Vedotin + Toripalimab, Probiotic + Disitamab Vedotin + Toripalimab |
Primary outcome
bladder-intact event free survival (BI-EFS), evaluated by independent review committee
Time frame: Up to approximately 3 years
Bladder intact event-free survival (BIEFS) refers to the time from the date of randomization to the first occurrence of any bladder preservation failure event through tumor control, whichever occurs first. Bladder preservation failure events include: 1. Rapid progression: progressive disease (PD) assessed by imaging at the mid-induction evaluation; 2. Tumor recurrence: ≥T2 stage, high-grade urothelial carcinoma (per the WHO 2016 Classification of Tumours of the Urinary System), or non-urothelial carcinoma histology; 3. Tumor metastasis: including lymph node metastasis and distant organ metastasis; 4. Death from any cause; 5. Receipt of radical cystectomy for any other reason.
3 secondary outcomes
clinical complete response (cCR)
Time frame: Up to approximately 3 years
Metastasis-free survival (MFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to qualified researchers, along with the study protocol and statistical analysis plan (SAP), after the publication of primary study results. Requests will be reviewed by the study sponsor and steering committee. Data will be shared via a secure, password-protected research data repository for non-commercial, scientific purposes only, in compliance with applicable regulations and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic, Disitamab Vedotin and Toripalimab in people with Muscle Invasive Bladder Cancer (MIBC), run by chenxu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junlin Lu, MD (+86-020-81332199, lujlin7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder-intact event free survival (BI-EFS), evaluated by independent review committee (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.