For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder preservation; in addition, a subset of patients have limited tolerance or eligibility to chemotherapy. Therefore, this study aims to evaluate the neoadjuvant regimen of Ruikang Trastuzumab combined with Camrelizumab, to determine whether this regimen can, with acceptable safety profiles: elevate pCR rate and the proportion of patients downstaged to ≤T1 disease, enable bladder preservation based on TURBT for eligible patients, and explore predictive biomarkers to identify the population most likely to derive clinical benefits.
Aged ≥18 years old with no restriction on gender.
Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance.
Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous/glandular differentiation is acceptable only when urothelial component dominates the lesion).
Clinically or radiologically diagnosed muscle-invasive bladder cancer (MIBC): cT2-T4a, N0-1, M0 per AJCC/UICC staging system; all imaging assessments shall be completed within 28 days prior to enrollment.
Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator.
Prior systemic anti-tumor therapy for current bladder cancer, including neoadjuvant/adjuvant/metastatic chemotherapy, immunotherapy or anti-HER2 agents; previous exposure to PD-1/PD-L1 inhibitors, anti-HER2 monoclonal antibodies or ADCs that may interfere with efficacy or safety evaluation per investigator's judgment.
Previous pelvic radiotherapy, or unrecovered major surgery/severe trauma within predefined time window before enrollment.
Active autoimmune disease or patients requiring long-term systemic immunosuppressive therapy (daily prednisone>10 mg or equivalent dose; topical/inhaled/short-course steroid use is permitted).
Single group
Trastuzumab Rezetecan plus Camrelizumab
DrugEligible screened participants will receive assigned treatment after satisfying all inclusion/exclusion criteria. Neoadjuvant Phase: Patients receive Trastuzumab Rezetecan (4.8 mg/kg, intravenous infusion) plus Camrelizumab (200 mg, intravenous infusion); each treatment cycle lasts 21 days, for a total of 2-3 cycles. Following a 2-4 week rest interval, clinical reassessment is performed prior to radical cystectomy (RC). Postoperative Adjuvant Phase: After surgery, Trastuzumab Rezetecan (4.8 mg/kg, IV infusion, once every 3 weeks for 6 cycles) and Camrelizumab (200 mg, IV infusion once every 3 weeks) are administered, with camrelizumab maintained for up to 1 year.
Pathological Complete Response Rate (pCR rate)
Proportion of patients achieving pathological complete response (pCR, no residual invasive urothelial carcinoma in bladder and regional lymph nodes) in surgical specimen after perioperative neoadjuvant therapy.
Event-Free Survival (EFS)
Time from study treatment initiation to first occurrence of local recurrence, distant metastasis, disease progression or all-cause death.
Overall Survival (OS)
Time from study treatment initiation to all-cause death of any reason.
Safety and Tolerability
Incidence, severity and causality of adverse events (AEs) graded per CTCAE v6.0 throughout perioperative treatment period.
Proportion of patients downstaged to T1 stage
Percentage of enrolled patients whose postoperative pathological tumor stage is downstaged to T1 after perioperative therapy.
Multi-omics spatial biomarkers predicting neoadjuvant treatment response
Correlation between pre-treatment tumor multi-omics profiles (WES whole exome sequencing, 10x Xenium spatial transcriptome, PhenoCycler-Fusion spatial single-cell proteomics) and pathological treatment response; explore predictive factors for perioperative regimen efficacy in HER2-positive MIBC.
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Sheng Tai
Lead sponsor
Anhui Medical University
Sponsor institution
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