A Phase 2/3 interventional study of Gemcitabine Submucosal Injection and Gemcitabine Intravesical Instillation in Non Muscle Invasive Bladder Cancer, sponsored by Shanghai University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 2/3, Interventional, and Treatment
Bladder cancer is the most common malignant tumor of the urinary system in China, and its incidence has been increasing year by year. It is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC accounts for 75% of newly diagnosed bladder cancer cases, and transurethral resection of bladder tumor (TURBT) followed by postoperative intravesical therapy is the standard treatment for NMIBC. However, the 5-year recurrence rate of NMIBC remains as high as 50%, with 20-30% of patients progressing to MIBC. MIBC is characterized by rapid progression and a high tendency for metastasis. The 5-year survival rate for patients with metastatic bladder cancer is only 5.4%. This study aims to investigate the efficacy of submucosal injection of the chemotherapeutic agent gemcitabine in preventing recurrence of intermediate- and high-risk NMIBC. Additionally, it seeks to develop software and devices related to submucosal injection to promote the clinical application of this new approach in the chemotherapeutic management of NMIBC. This research is expected to bring a revolutionary breakthrough in the standardisation of whole-process diagnosis and treatment of NMIBC, holding significant scientific value and major clinical translational importance for improving therapeutic outcomes and prognosis of bladder cancer.
Bladder cancer is a common malignant tumor of the urinary system. Globally, in 2023, there were approximately 610,000 new cases of bladder cancer and about 220,000 deaths attributed to the disease. In China, over the past two decades, the age-standardized incidence and prevalence rates of bladder cancer in men have increased by 71.79% and 195.38%, respectively. Over the last 15 years, the average annual mortality rate for male bladder cancer has risen by 3.84%, posing a serious threat to public health.
Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) based on whether the tumor invades the muscle layer. NMIBC accounts for approximately 75% of newly diagnosed bladder cancer cases. The standard treatment for NMIBC involves transurethral resection of bladder tumor (TURBT) followed by postoperative intravesical therapy. However, NMIBC often recurs within one year, with a recurrence rate as high as 60-70%, and 20-30% of cases progress to MIBC. Once bladder cancer advances to MIBC, it is characterized by rapid progression and a high tendency for metastasis. The standard treatment for MIBC is radical cystectomy with lymph node dissection, often accompanied by neoadjuvant or adjuvant chemotherapy. Traditional radical surgery for bladder cancer is highly invasive, associated with slow postoperative recovery and a high incidence of complications. The objective response rate for neoadjuvant or adjuvant chemotherapy is less than 50%. The 5-year survival rate for MIBC is below 60%, and for patients with distant metastasis, it drops significantly to just 5.4%.
In recent years, cancer immunotherapy, particularly immune checkpoint inhibitors, has advanced rapidly. However, immunotherapy also suffers from a low objective response rate, which is even below 30% in MIBC. Therefore, the high incidence, recurrence rate, and difficulty in curing bladder cancer remain significant challenges for both clinicians and patients.
TURBT is the standard surgical procedure for NMIBC. Intravesical therapy is a local adjuvant treatment used after TURBT to prevent recurrence. However, the efficacy of intravesical therapy is limited by inadequate drug absorption, resulting in insufficient local drug concentrations and suboptimal therapeutic outcomes. Moreover, postoperative intravesical therapy involves long-term, repeated invasive procedures, which often lead to complications such as urinary tract infections, bladder irritation, and urethral strictures. Improving the efficiency of drug utilization in intravesical therapy is a promising approach to address these issues. Enhancing drug absorption and prolonging the sustained-release effect of the agents could improve treatment efficacy while reducing the frequency of intravesical instillations, ultimately improving the prognosis of NMIBC, lowering recurrence rates, and reducing the risk of progression to MIBC. Submucosal injection of chemotherapeutic drugs offers a potential solution by increasing drug utilization efficiency and reducing complications associated with intravesical therapy.
265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.
This study's planned enrollment of 320 is above the median of 70 across 204 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients in this arm will receive submucosal injections of gemcitabine following transurethral resection of bladder tumor (TURBT). The regimen consists of one injection immediately after TURBT, followed by additional injections once every three months, for a total of four injections. Each injection uses 1000mg of gemcitabine. Injection sites are planned based on bladder area and common tumor locations, administered using a specialized injection gun.
Drug: Gemcitabine Submucosal Injection
Patients in this arm will receive standard intravesical instillation of gemcitabine following TURBT. The regimen consists of one instillation immediately after surgery, followed by an induction phase of once-weekly instillations for eight weeks, and then a maintenance phase of once-monthly instillations for ten months. Each instillation uses 2000mg of gemcitabine dissolved in 50mL of normal saline, retained for 30-60 minutes.
Drug: Gemcitabine Intravesical Instillation
A chemotherapeutic agent. Administered via submucosal injection into the bladder wall using a specialized injection gun. Dosage: 1000mg per injection. Regimen: One injection immediately post-TURBT, followed by one injection every three months for a total of four injections.
Standard therapy. Administered by instilling a solution into the bladder via a catheter. Dosage: 2000mg dissolved in 50mL normal saline per instillation. Regimen: One instillation immediately post-TURBT, followed by an induction phase (once weekly for 8 weeks) and a maintenance phase (once monthly for 10 months). The solution is retained for 30-60 minutes.
24-month Bladder Tumor Recurrence Rate
The proportion of patients with bladder tumor recurrence confirmed by cystoscopy and tissue biopsy within 24 months after transurethral resection of bladder tumor (TURBT). The recurrence rate is calculated as: (Number of patients with confirmed recurrence in the group / Total number of analyzed patients in that group) × 100%.
Time frame: 24 months post-operation
Proportion of Pathological Grade Upgrading upon Recurrence
The proportion of patients with recurrent tumor whose pathological grade (e.g., from low-grade to high-grade) is worse than at initial diagnosis among all patients with recurrence.
Time frame: Through study completion, up to 60 months
Tumor Complete Response (CR) Rate
The proportion of patients with no evidence of tumor recurrence, metastasis, or progression as confirmed by regular cystoscopy, biopsy, urinary cytology, and imaging.
Time frame: Through study completion, up to 60 months
Incidence of Bladder Irritation Symptoms and Gross Hematuria
Record and compare the proportion of patients in both groups experiencing bladder irritation symptoms (e.g., frequency, urgency, dysuria) and gross hematuria post-operation.
Time frame: Through study completion, up to 60 months
Change in Quality of Life Core Questionnaire (QLQ-C30) Score
Assessed using the EORTC QLQ-C30 questionnaire. It includes 5 functional scales, 3 symptom scales, and a global health status item. The change from baseline in scores will be used to evaluate the change in quality of life.
Time frame: Through study completion, up to 60 months
Change in Bladder Cancer-Specific Module (QLQ-BLM30) Score
Assessed using the EORTC QLQ-BLM30 module. It evaluates bladder cancer-specific quality of life dimensions such as urinary symptoms, physical function, and psychological state. The change from baseline in scores will be used for evaluation.
Time frame: Through study completion, up to 60 months
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the primary publications of this trial will be shared. This includes data on demographics, tumor characteristics, treatment allocation, recurrence, progression, safety, and quality of life scores.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine