Non Muscle Invasive Bladder Cancer
Conditions
Keywords
Urinary Bladder Neoplasms
Brief summary
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.
Interventions
Toripalimab 240 mg administered intravenously once every 3 weeks (Q3W), starting 4-8 weeks after surgery (after induction intravesical chemotherapy), given concurrently with maintenance intravesical gemcitabine, for 17 cycles or until disease progression, death, or unacceptable toxicity.
Gemcitabine 2000 mg administered by intravesical instillation, in three phases: (1) one immediate instillation (SI) after TURBT; (2) induction phase: once weekly for 4-8 instillations; (3) maintenance phase: once monthly for 12 instillations, given concurrently with toripalimab, until disease progression, death, or unacceptable toxicity.
Sponsors
Tianjin First Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (CR) Rate at 3 Months | 3 months after the first dose of study treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | From the first dose of study treatment until 1 month after the last dose (end of safety follow-up), or until the start of a new anti-cancer therapy, whichever occurs first. |
| Overall Survival (OS) | From enrollment to death from any cause, assessed up to approximately 5 years. |
Contacts
CONTACTQian Liu
Outcome results
None listed