Malignant bladder tumor
Conditions
Interventions
Experimental group:Induction Therapy: Subjects receive intravesical infusion of 240 mg toripalimab once weekly for up to 6 weeks.
Maintenance Therapy: After the completion of induction therapy, patien
Sponsors
The First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Subjects shall be over 18 years of age at the time of informed consent signing. 2.Diagnosis of high-risk non-muscle invasive bladder cancer (NMIBC) with BCG non-response after BCG therapy (at least five times weekly during the induction phase and no less than twice weekly during the maintenance phase). 3.Subjects who are ineligible for radical cystectomy or refuse to undergo radical cystectomy. 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0–2. 5.Adequate organ and bone marrow function, defined as follows: Hemoglobin> = 9.0 g/dL Absolute Neutrophil Count (ANC) > 1500/mm³ Platelet count > 100,000/mm³ Total serum bilirubin 40 mL/min (measured via the Cockcroft-Gault formula or 24-hour urine collection); no systemic corticosteroid administration within 4 weeks prior to treatment initiation. 6.Male subjects of reproductive potential and female subjects of childbearing potential must adopt effective contraceptive measures throughout the trial (e.g., oral contraceptives, intrauterine devices, or barrier contraception combined with spermicide), and continue contraception for 12 months upon treatment completion. 7.Subjects voluntarily participate in this study, sign the informed consent form, and are willing and able to comply with scheduled visits, treatment regimens, laboratory examinations and other study procedures.
Exclusion criteria
Exclusion criteria: 1.Patients meeting any of the following conditions will be excluded from the trial: 2.Muscle-invasive, locally advanced unresectable or metastatic urothelial carcinoma. 3.Clinically significant multiple or severe drug allergies, intolerance to topical glucocorticoids, or severe hypersensitivity reactions after treatment (including but not limited to Stevens-Johnson syndrome, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis and exfoliative dermatitis). 4.Severe active infection within 2 weeks prior to randomization, including tuberculosis requiring systemic treatment with oral or intravenous antibiotics. Patients receiving prophylactic antibiotics (e.g., for urinary tract infection prevention) are eligible. 4.Prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies. 5.Prior treatment with immunostimulants, including interleukin (IL)-2, IL-15, and interferon (INF)-?. 6.Prior pelvic radiation therapy for the bladder. 7.Vaccination is prohibited within 4 weeks before randomization and during the study treatment period, except for inactivated vaccines. 8.Conditions requiring systemic corticosteroids (equivalent to >10 mg prednisone daily) or other immunosuppressive drugs within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement doses equivalent to >10 mg prednisone daily are permitted in the absence of active autoimmune disease. 9.Participation in other investigational drug studies within 4 weeks prior to randomization. 10.Pregnant or lactating women. 11.Active infections, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. Subjects with previous or resolved HBV infection are eligible for enrollment. Subjects positive for HCV antibodies are eligible only if HCV RNA polymerase chain reaction testing is negative. 12.Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., with disease-modifying drugs, corticosteroids, or immunosuppressive medications); relevant replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are permitted. 13.Uncontrolled concomitant diseases, including but not limited to: ongoing active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, severe chronic gastrointestinal diseases associated with diarrhea, or psychiatric/social conditions that may impair protocol compliance, significantly increase the risk of adverse events, or compromise the patient’s ability to provide written informed consent. 14.Major surgery (as defined by the investigator) performed within 28 days prior to the first study drug administration. 15.Massive pleural effusion or ascites with clinical symptoms or requiring symptomatic management. 16.Total urinary incontinence of the bladder, defined as the use of more than 6 pads within a 24-hour period. 17.Other severe, acute or chronic medical or psychiatric illnesses, or laboratory abnormalities that, in the investigator’s judgment, may increase the risks associated with study participation or interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year high-grade recurrence-free rate(HGR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival(RFS);Progression-Free Survival(PFS); | — |
Countries
China
Contacts
Public ContactWang Wenguang
The First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed