Trial Radar IA
Lo studio clinico NCT07474064 per Muscle Invasive Bladder Cancer (MIBC) è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC Fase II 146 Immunoterapia Terapia mirata

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07474064 è uno studio interventistico di Fase II volto a esaminare il trattamento per Muscle Invasive Bladder Cancer (MIBC), attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 26 marzo 2026, con l'obiettivo di raggiungere 146 partecipanti. Sotto la guida di chenxu, dovrebbe concludersi entro il 31 marzo 2035. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 17 marzo 2026.
Sommario breve
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 w...

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Titolo ufficiale

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

Patologie
Muscle Invasive Bladder Cancer (MIBC)
Altri ID dello studio
  • PTI-BPS-2026-IIT
Numero NCT
NCT07474064
Data di inizio (effettiva)
2026-03-26
Ultimo aggiornamento pubblicato
2026-03-17
Data di completamento (stimata)
2035-03-31
Arruolamento (previsto)
146
Tipo di studio
Interventistico
FASE
Fase II
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleProbiotic + Disitamab Vedotin + Toripalimab
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).
Probiotico
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 Vedotin
2.0 mg/kg IV every 2 weeks during the induction treatment period and intensive treatment period
Toripalimab
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.
Comparatore attivoDisitamab Vedotin + Toripalimab
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).
Disitamab Vedotin
2.0 mg/kg IV every 2 weeks during the induction treatment period and intensive treatment period
Toripalimab
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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
Up to approximately 3 years
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
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.
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.
Up to approximately 3 years
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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.

  • 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).
  • 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.
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Parte responsabile dello studio
chenxu, Promotore-investigatore, PhD, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contatti principali dello studio
Contatto: Junlin Lu, MD, +86-020-81332199, [email protected]
1 Centri dello studio in 1 paesi

Guangdong

Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, 510120, China
Li Yan, Contatto, +86-020-81332587, [email protected]
Xu Chen, PhD, MD, Investigatore principale
Tianxin Lin, PhD, MD, Investigatore principale
Junlin Lu, MD, Sub-investigatore