Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer

NCT06916494 | Recruiting Phase 1 DMC

• 1 other identifier: ZZ2025-070-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment.
2. 2.Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients.
3. 3.Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.

Conditions

Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor microenvironment

  Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (2)

• Safety and adverse events

  From enrollment to the end of treatment at 6 weeks

• Objective remission rate

  From enrollment to the end of treatment at 6 weeks

Study Arms (1)

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.

Drug: Rutin; Drug: Gemcitabine, Cisplatin; Drug: Tislelizumab

Interventions

Rutin DRUG

Rutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle)

Rutin combined with Tislelizumab and GC

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)

Rutin combined with Tislelizumab and GC

Tislelizumab DRUG

Tislelizumab 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle)

Rutin combined with Tislelizumab and GC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Interventions

Rutin; Gemcitabine; Cisplatin; tislelizumab

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xin Gou, Professor

  The First Affiliated Hospital of Chongqing Medica University

  STUDY CHAIR

Central Study Contacts

Xin Gou, Professor

CONTACT

0086+13650518875; cymnk@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: May 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD and supporting information will be available after 2027.12.31
• Access Criteria: Study protocal of the study is available from professor Xin Gou (email:cymnk@163.com)

Locations

CN (1)