Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarbin Medical University

About this trial

This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.

Eligibility criteria

Qualifiers

Age ≥18 years.

ECOG performance status of 0 or 1.

Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).

Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).

Disqualifiers

Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.

Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks before the first dose.

History of severe allergic reactions to other monoclonal antibodies.

Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose >10 mg/day prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.

Trial design

Treatments tested in this trial

  • Trastuzumab Rezetecan Combined with Adebelizumab

Treatment groups

58 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Harbin Medical University

Lead sponsor

The Fourth Affiliated Hospital of China Medical University

Collaborator

Jilin Provincial Tumor Hospital

Collaborator

Tianjin Medical University Second Hospital

Collaborator

First Hospital of China Medical University

Collaborator