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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, tislelizumab |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | January 20, 2026 |
| Study ends | January 20, 2026 |
| Registry record updated | April 10, 2025 |
| Trial ID | NCT06916494 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
- Study coordinator: Xin Gou, Professor
- Email: cymnk@163.com
- Phone: 0086+13650518875
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy
This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.
-
SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy
This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.
-
Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX
This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.
-
Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC
This phase II trial tests whether adding tislelizumab and anlotinib after chemoradiotherapy helps people with limited-stage small cell lung cancer stay cancer-free.
-
Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
-
QLC5508 plus QL2107 vs tislelizumab plus platinum chemotherapy as first treatment for extensive-stage small cell lung cancer
This phase 3 trial tests whether QLC5508 with QL2107 works better than tislelizumab with platinum chemotherapy for adults with untreated extensive-stage small cell lung cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.