Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06916494

Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy 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:

1. Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment. 2. Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients. 3. 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Muscle Invasive Bladder Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location status: Recruiting

Location contact

Xinyuan Li, Attending Physician

CONTACT

[email protected]

13650518875

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rutin

Drug

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

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety and adverse events

    Time frame: From enrollment to the end of treatment at 6 weeks

    The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.

  2. Objective remission rate

    Time frame: From enrollment to the end of treatment at 6 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Gou, Professor

CONTACT

[email protected]

0086+13650518875

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.