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New treatment option for Bladder Cancer
Official title Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration
ClinicalTrials.gov ID: NCT07307456
What this study is testing
What is Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT)?
Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital. The Principal Investigators are Professor Zhang Zhensheng and Professor Chen Guanghua.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years.
- Patients with a pathological diagnosis of high-risk or very high-risk non-muscle-invasive bladder cancer (NMIBC) following transurethral resection or...
- All T1 high-grade (HG)/G3 without carcinoma in situ (CIS), excluding those in the very high-risk group.
- All CIS patients, excluding those in the very high-risk group.
- Ta low-grade (LG)/G2 or T1 G1 without CIS, accompanied by three risk factors.
You likely can't join if
- Patients meeting any of the following criteria were excluded from this study:
- History or presence of muscle-invasive or disseminated/metastatic bladder cancer. Patients with locally advanced or metastatic bladder cancer or...
- Prior surgical intervention for bladder cancer other than transurethral resection of bladder tumor (TURBT) and/or bladder biopsy.
- Administration of any other approved systemic anticancer therapy or systemic immunomodulatory agents (including, but not limited to, interferon...
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment.
- Major surgery or significant trauma within 28 days prior to enrollment.
See the full eligibility criteria
- Age 18-75 years.
- Patients with a pathological diagnosis of high-risk or very high-risk non-muscle-invasive bladder cancer (NMIBC) following transurethral resection or cystoscopic biopsy. "High-risk patients" must meet any one of the...
- All T1 high-grade (HG)/G3 without carcinoma in situ (CIS), excluding those in the very high-risk group.
- All CIS patients, excluding those in the very high-risk group.
- Ta low-grade (LG)/G2 or T1 G1 without CIS, accompanied by three risk factors.
- Ta HG/G3 or T1 LG without CIS, accompanied by at least two risk factors.
- T1 G2 without CIS, accompanied by at least one risk factor. "Very high-risk patients" must meet any one of the following criteria: (1) Ta HG/G3 with CIS accompanied by three risk factors. (2) T1 G2 with CIS accompanied...
- Patients meeting any of the following criteria were excluded from this study:
- History or presence of muscle-invasive or disseminated/metastatic bladder cancer. Patients with locally advanced or metastatic bladder cancer or concurrent upper tract urothelial carcinoma were excluded.
- Prior surgical intervention for bladder cancer other than transurethral resection of bladder tumor (TURBT) and/or bladder biopsy.
- Administration of any other approved systemic anticancer therapy or systemic immunomodulatory agents (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) within 28 days prior to...
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment.
- Major surgery or significant trauma within 28 days prior to enrollment.
- Vaccination with a live vaccine within 28 days prior to enrollment.
- Use of any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days prior to enrollment.
- Treatment with systemic corticosteroids within 4 weeks prior to the study intervention.
- Active autoimmune diseases requiring systemic treatment or other conditions necessitating long-term use of high-dose corticosteroids and other immunosuppressive agents.
- History of potassium, sodium, or calcium abnormalities, hypoalbuminemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (including diabetes, hypertension, cardiovascular...
- Active viral hepatitis B or C. Patients with acute or chronic active hepatitis B or C infection were excluded if they met any of the following criteria: hepatitis B virus (HBV) DNA \>2000 IU/mL or 10⁴ copies/mL...
- Known history of human immunodeficiency virus (HIV) infection or known diagnosis of acquired immunodeficiency syndrome (AIDS) (no screening tests were required).
- History of any organ transplantation, including allogeneic stem cell transplantation, except for transplants not requiring immunosuppression (e.g., corneal transplant, hair transplant).
- Known history of allergic reactions to any of the study drugs.
- Concurrent participation in another clinical trial.
- History and/or concurrent presence of other malignancies, except for: malignancies treated with curative intent with no recurrence for over 3 years, or early-stage cancers considered cured, including completely resected...
- Active central nervous system metastases or carcinomatous meningitis.
- Any condition that, in the investigator's opinion, rendered the patient unsuitable for study participation (e.g., treatment not in the patient's best interest, poor patient compliance, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.