non-muscle invasive bladder cancer
Conditions
Interventions
iNKT-treated group:iNKT immunotherapy
conrol group:routine treatment
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 75 years; (2) NMIBC patients whose lesions can be removed by TURBT surgery; (3) Expected survival =12 months at least 2 weeks after TURBT surgery; (4) Blood routine: hemoglobin (HGB) =80 g/L, absolute neutrophil count (ANC) =1×109/L, platelet count (PLT) =30×109/L, and white blood cell count (WBC) >2.5×109/L; (5) Subjects without dysfunction of major organs, blood routine, lung, liver, kidney function and cardiac function are basically normal; (6) Physical condition ECOG score =2; (7) Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age agree to use effective contraception throughout the treatment period and for 6 months after the treatment period. (8) The person himself/herself or his/her legal representative may sign an informed consent form and is willing to comply with the visits and related procedures stipulated in the program.
Exclusion criteria
Exclusion criteria: (1) Surgery (excluding TURBT or cystoscopy), radiotherapy or systemic chemotherapy within 4 weeks prior to enrollment; (2) Severe hepatic and renal function abnormalities: ALT (alanine aminotransferase) >50 U/L, AST (aspartate aminotransferase) >40 U/L, Tbil (total bilirubin) >20.4 µ-mol/L, serum creatinine >115 µ-mol/L, and INR (international normalized ratio) >1.2 s; (3) Patients with shock, vital organ failure, and unstable vital signs; (4) Severe coagulation disorders (e.g. hemophilia); (5) Patients who are highly allergic or have a history of severe allergy, combined with severe autoimmune diseases or are receiving immunosuppressive therapy; (6) Patients with clinically serious uncontrolled or active infections such as acute pneumonia, active hepatitis B, and patients with T-cell lymphoma, syphilis, or AIDS or a combination of these; (7) Combined mental or psychological illnesses who cannot cooperate with the treatment and efficacy assessment; (8) Pregnant or lactating women, or women of childbearing age who refuse to use contraception during the study period; (9) Those who, in the opinion of the physician, also have other reasons for not being included in the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactTongyu Zhu/Xiaoyan Zhang
Zhongshan Hospital, Fudan University
Outcome results
None listed