Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Combining rutin with immunotherapy and chemotherapy for bladder cancer treatment

Official title: A Single-Arm, Open-Label, Multicenter Pilot Study:Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer

Run by First Affiliated Hospital of Chongqing Medical University · NCT06916494 · Data updated 2026-11-12

This study is testing if adding rutin to standard bladder cancer treatments can help patients whose cancer hasn't responded to chemotherapy feel better and improve their outcomes.

More Muscle-invasive Bladder Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorFirst Affiliated Hospital of Chongqing Medical University
Academic / other
Drugs / interventionschemotherapy, immunotherapy, tislelizumab
Locations1 site (Chongqing, Chongqing Municipality)
StatusRecruiting
StartedMay 1, 2025
Main results expectedJanuary 20, 2026
Study endsJanuary 20, 2026
Registry record updatedApril 10, 2025
Trial IDNCT06916494 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with muscle-invasive bladder cancer who have not responded to prior neoadjuvant chemotherapy.

Probably not a fit

Patients with severe comorbidities or those under 18 years old may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the efficacy and safety of rutin combined with tislelizumab and gemcitabine/cisplatin (GC) as neoadjuvant therapy for patients with platinum-refractory muscle-invasive bladder cancer (MIBC). The study focuses on understanding how rutin may influence epigenetic mechanisms and the tumor immune microenvironment in these patients. Participants who show no response after two cycles of GC chemotherapy will receive the combination treatment, with safety and therapeutic responses monitored through MRI assessments. The trial aims to provide insights into the biological mechanisms of this combination therapy.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with platinum-refractory muscle-invasive bladder cancer.

How similar studies have gone: While this approach is novel, similar studies combining immunotherapy with chemotherapy have shown promise in other cancer types.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC)
* No response after 2 cycles of GC neoadjuvant chemotherapy
* No prior use of systemic immunotherapy or target therapy
* Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline
* ECOG (ZPS, 5-point scale) 0-1

Exclusion Criteria:

* Age less than 18 years
* Patients with severe cardiac, cerebral, hepatic, or renal disease
* Severely malnourished patients
* Patients with mental illness and those without insight and unable to express exactly
* Combined with malignant tumors of other organs
* Systemic infectious diseases

Where it's running

  • First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.