Muscle Invasive Bladder CancerPhase 1NCT06916494
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer
A Phase 1 study testing Rutin, Gemcitabine, Cisplatin and Tislelizumab in people with Muscle Invasive Bladder Cancer, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- Rutin, Gemcitabine, Cisplatin and Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 20 Jan 2026
- Phase
- Phase 1
- 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 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Xinyuan Li, Attending Physician, 13650518875, lixinyuan@sibcb.ac.cn
About this study
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
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:
- Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment.
- Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients.
- Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.
Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- Rutin, Gemcitabine, Cisplatin, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RutinDrug
Rutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle)
Gemcitabine, CisplatinDrug
Cisplatin 100 mg/m² D2 q3w, and Gemcitabine 1000 mg/m² D1, D8 q3w. Treatment will be given for 2 cycles (21 days per cycle)
TislelizumabDrug
Tislelizumab 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| Rutin combined with Tislelizumab and GC | Experimental | Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w) will receive two cycles of rutin (40 mg tid.) combined with tislelizumab (200 mg D1 q3w) and GC (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w). Safety and adversed events will be assessed after every cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and changes in the immune microenvironment will be analyzed post-treatment. Receives: Drug: Rutin; Drug: Gemcitabine, Cisplatin; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor microenvironment
Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
Safety and adverse events
The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.
Measured: From enrollment to the end of treatment at 6 weeks
Objective remission rate
The proportion of patients with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) after treatment was calculated according to established response evaluation criteria (Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1).
Definitions:
CR (Complete Response): Disappearance of all target lesions with no new lesions.
PR (Partial Response): ≥30% decrease in the sum of diameters of target lesions. SD (Stable Disease): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
PD (Progressive Disease): ≥20% increase in the sum of diameters of target lesions and/or appearance of new lesions
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2026 (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 CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Gou, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Xin Gou, Professor, Study chair, The First Affiliated Hospital of Chongqing Medica University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916494
- Sponsor's protocol ID
- ZZ2025-070-02
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study outcomes and follow-up information will be available after paper publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916494
- Acronym / sponsor ID
- ZZ2025-070-02
- Conditions
- Muscle Invasive Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:
- Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment.
- Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients.
- Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.
Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rutin combined with Tislelizumab and GC | Experimental | Drug: Rutin, Drug: Gemcitabine, Cisplatin, Drug: TislelizumabPatients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w) will receive two cycles of rutin (40 mg tid.) combined with tislelizumab (200 mg D1 q3w) and GC (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w). Safety and adversed events will be assessed after every cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and changes in the immune microenvironment will be analyzed post-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| RutinRutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle) | Drug | Rutin combined with Tislelizumab and GC |
| Gemcitabine, CisplatinCisplatin 100 mg/m² D2 q3w, and Gemcitabine 1000 mg/m² D1, D8 q3w. Treatment will be given for 2 cycles (21 days per cycle) | Drug | Rutin combined with Tislelizumab and GC |
| TislelizumabTislelizumab 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle) | Drug | Rutin combined with Tislelizumab and GC |
Primary outcome
Tumor microenvironment
Time frame: From enrollment to the end of treatment at 6 weeks
Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.
2 secondary outcomes
Safety and adverse events
Time frame: From enrollment to the end of treatment at 6 weeks
Objective remission rate
Time frame: From enrollment to the end of treatment at 6 weeks
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 10 Apr 2025.
- Individual participant dataSharing planned: Yes. The study outcomes and follow-up information will be available after paper publication.
Related trials for Muscle Invasive Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
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.
Xin Gou, Professor study chair
The First Affiliated Hospital of Chongqing Medica University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rutin, Gemcitabine, Cisplatin and Tislelizumab in people with Muscle Invasive Bladder Cancer, run by First Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xin Gou, Professor (0086+13650518875, cymnk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor microenvironment (time frame: From enrollment to the end of treatment at 6 weeks). 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 10 Apr 2025.