Combining rutin with immunotherapy and chemotherapy for bladder cancer treatment
A Single-Arm, Open-Label, Multicenter Pilot Study：Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer
PHASE1 · First Affiliated Hospital of Chongqing Medical University · NCT06916494
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.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University (other) |
| Drugs / interventions | chemotherapy, immunotherapy, tislelizumab |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06916494 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with muscle-invasive bladder cancer who have not responded to prior neoadjuvant chemotherapy.
Not a fit: Patients with severe comorbidities or those under 18 years old may not benefit from this study.
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 performed: While this approach is novel, similar studies combining immunotherapy with chemotherapy have shown promise in other cancer types.
Eligibility criteria
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 this trial is running
Chongqing, Chongqing Municipality
- First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Xin Gou, Professor
- Email: cymnk@163.com
- Phone: 0086+13650518875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Muscle Invasive Bladder Cancer