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

NCT ID: NCT06916494

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-20

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. 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.

Conditions

Muscle Invasive Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rutin combined with Tislelizumab and GC

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.

Group Type: EXPERIMENTAL

Rutin

Intervention Type: DRUG

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

Gemcitabine, Cisplatin

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Rutin

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

Intervention Type: DRUG

Gemcitabine, Cisplatin

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)

Intervention Type: DRUG

Tislelizumab

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xin Gou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Gou, Professor

Role: STUDY_CHAIR

The First Affiliated Hospital of Chongqing Medica University

Locations

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Gou, Professor

Role: CONTACT

cymnk@163.com

0086+13650518875

Facility Contacts

Xinyuan Li, Attending Physician

Role: primary

lixinyuan@sibcb.ac.cn

13650518875

Other Identifiers

ZZ2025-070-02

Identifier Type: -

Identifier Source: org_study_id