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

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:

• HIV infection (HIV antibody positive).
• Active or clinically uncontrolled severe infection.
• 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).
• 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.