High-risk non-muscle-invasive bladder urothelial carcinoma
Conditions
Interventions
Experimental group(HR-NMIBC):Disitamab Vedotin combined with Toripalimab for targeted immunotherapy
Sponsors
ZhangZhou Municipal Hospital of Fujian province
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily agree to participate in the study and sign the informed consent form; 2.Males or females aged between 18 and 85; 3.The expected survival duration is >=12 weeks; 4.High-risk non-muscle-invasive bladder urothelial carcinoma with histopathologically confirmed HER2 overexpression. HER2 overexpression is defined as a HER2 immunohistochemical score of 2+ or 3+; 5.The subjects are able to provide tumor primary site specimens for PD-L1 and HER2 detection; with HER2 IHC being 2+ or 3+; 6.ECOG performance status score of 0-1; 7.Sufficient heart, bone marrow, liver, and kidney function (based on the normal values of the research center); (1) Left ventricular ejection fraction >= 50%; (2). Hemoglobin >= 9g/dl; (3). Absolute neutrophil count (ANC) >= 1.5 × 10 ^ 9/L; (4). Platelet >= 100 × 10 ^ 9/L; (5). Serum total bilirubin = 60 [ml · min-1 · (1.73 m ^ 2) -1]; 8.For female subjects: They should be patients who have undergone surgical sterilization or are postmenopausal, or who agree to adopt at least one medically approved contraceptive measure (such as an intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and for at least 6 months after its conclusion. Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment, and they must not be breastfeeding. Male subjects should agree to adopt at least one medically approved contraceptive measure (such as condoms, abstinence, etc.) during the study treatment period and for at least 6 months after its conclusion; 9.Willing and able to comply with the trial and follow-up procedure arrangements.
Exclusion criteria
Exclusion criteria: 1.Received attenuated live vaccines within 4 weeks before enrollment or plan to receive them during the study period; 2.Active, known, or suspected autoimmune diseases; 3.Known history of primary immunodeficiency; 4.History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation is known; 5.Female patients who are pregnant or breastfeeding; 6.Individuals with untreated acute or chronic active hepatitis B or C infection. For patients undergoing antiviral treatment, their eligibility for enrollment will be determined by their physicians based on individual circumstances while monitoring viral copy numbers; 7.Uncontrolled concurrent diseases, including but not limited to: (1). HIV-infected individuals (HIV antibody positive); (2). Severe infections in the active phase or with poor clinical control; (3) Evidence of severe or uncontrollable systemic diseases (such as severe mental or neurological disorders, epilepsy or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic, or renal diseases, uncontrolled hypertension [i.e., hypertension greater than or equal to CTCAE Grade 2 despite pharmacological treatment]); (4). Individuals with active bleeding or new thrombotic diseases who are taking therapeutic doses of anticoagulant drugs or have a tendency to bleed; 8.Other situations that researchers consider unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month event-free survival rate(EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Overall Survival(OS);Adverse Event(AE);3-month pathological complete remission (CR) rate; | — |
Countries
China
Contacts
Public ContactHaili Lin
ZhangZhou Municipal Hospital of Fujian province
Outcome results
None listed