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A prospective, multicenter, two-arm, randomized controlled study of the efficacy and safety of transurethral resection of bladder tumor combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade and T2 bladder cancer

A prospective, multicenter, two-arm, randomized controlled study of the efficacy and safety of transurethral resection of bladder tumor combined with chemotherapy and immunotherapy in bladder-sparing therapy in patients with T1 high-grade and T2 bladder cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060546
Enrollment
Unknown
Registered
2022-06-04
Start date
2022-05-27
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Experimental group:TURBT combined with chemotherapy and immunotherapy
Control group:TURBT combined with chemotherapy

Sponsors

The Seventh Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are unwilling to accept or cannot tolerate radical cystectomy voluntarily participate in and sign informed consent based on fully understanding the clinical trial; 2. Patients diagnosed with T1 high-grade or T2 bladder cancer; 3. 18-75 years old; 4. The pathological type is urothelial carcinoma; 5. Return to the hospital regularly; 6. Can be followed up for at least one year.

Exclusion criteria

Exclusion criteria: 1. Chemotherapy contraindications (PS score > 1, GFR = 2, peripheral neuropathy, NYHA grade III heart failure or above); 2. Allergic to chemotherapeutic drugs or immunotherapy drugs; 3. Combined with lymph node metastasis or distant metastasis; 4. Pregnant or breastfeeding patients; 5. Combined with other malignant tumors; 6. Combined with radiotherapy, another intravesical instillation therapy except for intraoperative intravesical instillation chemotherapy, or other anti-tumor treatments; 7. Combined with autoimmune diseases or long-term use of immunosuppressive drugs (including prednisone > 10mg/day); 8. Combined with severe cardiovascular, respiratory, liver, and kidney diseases or poor blood sugar control; 9. Combined with mental disorders; 10. Poor compliance; 11. Combined with other clinical and laboratory conditions not suitable to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
Pathologic response rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;Incidence of side effects;Quality of life;

Countries

China

Contacts

Public ContactPang Jun

The Seventh Affiliated Hospital of Sun Yat-Sen University

pangjun2@mail.sysu.edu.cn+86 18802044177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026