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Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma
Sponsor: Sheng Tai
Summary
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.
Official title: Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined With Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-06-05
Completion Date
2028-12-31
Last Updated
2026-06-10
Healthy Volunteers
No
Interventions
Trastuzumab Rezetecan plus Camrelizumab
Eligible 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.