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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rutin | Drug | Rutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor microenvironment | Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components. | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events | The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0. | From enrollment to the end of treatment at 6 weeks |
| Objective remission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Gou, Professor | Contact | 0086+13650518875 | cymnk@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Gou, Professor | The First Affiliated Hospital of Chongqing Medica University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
The study outcomes and follow-up information will be available after paper publication.
The IPD and supporting information will be available after 2027.12.31
Study protocal of the study is available from professor Xin Gou (email:cymnk@163.com)
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| Gemcitabine, Cisplatin | Drug | 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) |
|
| Tislelizumab | Drug | Tislelizumab 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle) |
|
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
| From enrollment to the end of treatment at 6 weeks |
| ID | Term |
|---|---|
| D012431 | Rutin |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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