Patients with HER2-positive muscle-invasive urothelial carcinoma
Conditions
Interventions
Trial Group:Perioperative Treatment with Trastuzumab?Rezetecan Combined with Camrelizumab
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, no restriction on gender; 2. Voluntarily participate in the study, sign a written informed consent form, and maintain good compliance 3. Confirmed as urothelial carcinoma of the bladder by histopathology (presence of squamous or glandular components is permitted, provided urothelial carcinoma constitutes the predominant component); 4. Patients are diagnosed with muscle-invasive bladder cancer (MIBC) via imaging or clinical assessment: cT2–T4a, N0–1, M0 (staged per AJCC/UICC criteria; imaging evaluations must be completed within the specified time window prior to enrollment, e.g., within 28 days); 5. Positive HER2 expression in tumor: IHC 1+, 2+ or 3+ (tested on tumor tissue specimens obtained prior to enrollment; central laboratory/designated laboratory testing may be specified); 6. ECOG performance status of 0–1; 7. Eligibility for radical surgical treatment: Radical cystectomy (RC) is expected to be feasible; and investigators assess that subsequent TURBT can be performed in line with the study protocol; 8. Major organ functions meet the treatment criteria (threshold values are recommended as exemplified below): Blood routine: ANC >=1.5×10^9/L, PLT >=100×10^9/L, Hb >=90 g/L; Liver function: ALT/AST =50 mL/min (calculated via Cockcroft–Gault or MDRD formula); Satisfactory cardiac function: echocardiographic LVEF >=50% (or threshold set per local hospital standards or clinical guidelines) with no obvious heart failure symptoms (due to trastuzumab-containing regimen); 9. Subjects of childbearing age agree to use effective contraception during the study period and within the specified time after the last dose administration.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis (M1) or unresectable/inoperable disease; or those complicated with other active tumor burdens requiring systemic treatment (as judged by the investigator); 2. Prior receipt of systematic anti-tumor therapy for the current malignancy (such as neoadjuvant/adjuvant/metastatic-phase chemotherapy, immunotherapy, anti-HER2 therapy, etc.); or prior treatment with PD-1/PD-L1 inhibitors, anti-HER2 monoclonal antibodies/ADCs, which the investigator deems capable of affecting efficacy or safety assessment; 3. Prior pelvic radiotherapy or unrecovered major surgery/severe trauma in the recent period (subject to specified time limits); 4. Individuals with active autoimmune diseases or those requiring systemic immunosuppressive therapy (e.g., long-term hormone treatment with prednisone >10 mg per day or equivalent dosage; topical, inhaled or short-course medication is permitted); 5. Uncontrolled active or severe infection; active tuberculosis. Viral infections: positive HBsAg with HBV DNA above the threshold or without standardized antiviral treatment; positive HCV RNA with uncontrolled disease; HIV infection (subject to the requirements of the study center). Clinically significant cardiovascular diseases: congestive heart failure, recent myocardial infarction, unstable angina pectoris, refractory arrhythmia; LVEF <50% or subjects deemed inappropriate for trastuzumab administration by the investigator; 6. Previous or current interstitial lung disease/non-infectious pneumonia, or significant interstitial lung abnormalities on imaging assessed by the investigator to carry a high risk (risk of immune-related pneumonia); 7. Known severe hypersensitivity to the investigational medicinal products (trastuzumab, camrelizumab) or their excipients; pregnant or breastfeeding patients; those planning to become pregnant during the study period; 8. Those complicated with severe mental/cognitive disorders, substance abuse or other conditions that prevent completion of follow-up or assessment; 9. Other conditions deemed ineligible for enrollment by the investigators (such as severe comorbidities, too short expected survival time, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate (pCR rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Event-Free Survival (EFS);Proportion of patients downstaged to pathological T1 stage;Safety and Tolerability;Multiomics spatial biomarkers for neoadjuvant therapeutic response prediction; | — |
Countries
China
Contacts
Public ContactSheng Tai
The first affiliated hospital of anhui medical university
Outcome results
None listed