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Patient-Derived Tumor-Like Cell Clusters for Adjuvant Intravesical Chemotherapy in Patients with Intermediate/High-Risk Non-Muscle Invasive Bladder Cancer: a Randomized Controlled Clinical Trial

Patient-Derived Tumor-Like Cell Clusters for Adjuvant Intravesical Chemotherapy in Patients with Intermediate/High-Risk Non-Muscle Invasive Bladder Cancer: a Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040996
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-12-14
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Bladder Cancer

Interventions

Control group:Epirubicin
Drug Screening Group:Screening Drug

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the trial and sign a written informed consent; 2. Patients are >= 18 years old and <= 85 years old, regardless of gender; 3. Patients undergoing transurethral resection of bladder tumors; 4. Histologically diagnosed as non-muscular infiltration Urothelial carcinoma of the bladder, refer to the 2014 version of CUA diagnosis and treatment guidelines for bladder cancer to assess patients with a high risk of recurrence or progression; (for patients who are considering secondary resection, the pathological results can be confirmed Medium and high-risk non-muscular invasive urothelial carcinoma of the bladder will be included in the study); 5. No history of other malignant tumors in the past; 6. ECOG score: 0-2 points.

Exclusion criteria

Exclusion criteria: 1. Patients with muscular invasive bladder urothelial carcinoma (T2 stage and above); 2. Combined with tumors of other genitourinary system or other organs; 3. Patients who have received chemotherapy, radiotherapy, immunotherapy in the past 4 weeks (except immediately after surgery)(Except bladder perfusion chemotherapy); 4. Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those who plan to conceive during the trial period (including the pregnancy of the male subjects partner); 5. Bladder perforation is known or suspected during the operation; 6. There was gross hematuria before admission, and it is suspected that the surgical wound was not healed or the urinary tract mucosa was damaged; 7. With cystitis, or had received other bladder infusion medications and severe bladder irritation is expected to affect the evaluation of this study; 8. In Participated in clinical trials of other drugs within the first 3 months of the group; 9. Known opioid or alcohol dependence; 10. Severe blood coagulation abnormalities, electrolyte balance disorders, and hypoalbuminemia have not improved significantly after active correction; 11. The researchers believe There may be any situation that increases the risk of subjects or interferes with the execution of clinical trials.

Design outcomes

Primary

MeasureTime frame
3 year recurrence-free survival rate;

Countries

China

Contacts

Public ContactWei Zhang

Second Hospital of Tianjin Medical University

Han2001han@sina.com+86 15822570371

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026