Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer After TURBT

A Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy After Transurethral Resection of Bladder Tumor (TURBT) in Patients With High-Risk Urothelial Carcinoma

This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). Patients with high-risk NMIBC are planned to be enrolled. Treatment consists of one immediate intravesical instillation of gemcitabine after TURBT, followed by induction intravesical chemotherapy with gemcitabine for 4-8 instillations, and then maintenance treatment with toripalimab combined with intravesical gemcitabine 2000 mg once monthly for 12 instillations.

Inclusion Criteria:

• Patients with high-risk non-muscle-invasive urothelial carcinoma after TURBT who have not received prior BCG therapy.
• Male or female, aged 18 to 85 years.
• Life expectancy of more than 12 weeks.
• ECOG performance status of 0 to 2.
• No prior immunotherapy or other systemic therapy for the disease under study.
• Adequate organ function.
• Willing and able to comply with the study procedures and follow-up schedule.
• Ability to understand and willingness to voluntarily sign the informed consent form (ICF).

Exclusion Criteria:

• Receipt of a live attenuated vaccine within 4 weeks prior to enrollment, or planned receipt during the study period.

• Active, known, or suspected autoimmune disease.

• Known history of primary immunodeficiency.

• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

• Pregnant or breastfeeding women.

• Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.

• Uncontrolled comorbidities, including but not limited to the following:

  1. HIV infection (HIV antibody positive).
  2. Active or clinically uncontrolled severe infection.
  3. Evidence of severe or uncontrolled systemic disease, including but not limited to severe psychiatric or neurological disorders, epilepsy or dementia; unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease; or uncontrolled hypertension (≥ CTCAE grade 2 despite medical therapy).
  4. Active bleeding, newly diagnosed thromboembolic disease requiring therapeutic-dose anticoagulation, or bleeding diathesis.

• Known hypersensitivity to the investigational drugs (toripalimab or gemcitabine).

• Any other condition judged by the investigator to render the patient unsuitable for enrollment.

• Concurrent participation in another clinical study.