74
Participants
Start Date
January 1, 2024
Primary Completion Date
December 1, 2025
Study Completion Date
January 1, 2026
Disitamab Vedotin (RC48)
A HER2-targeted antibody-drug conjugate comprising a humanized anti-HER2 monoclonal antibody linked via a cathepsin-cleavable MC-VC-PAB linker to the microtubule inhibitor MMAE (drug-to-antibody ratio ≈4). Administered intravenously at 2.0 mg/kg every 2 weeks.
Bevacizumab
A recombinant humanized monoclonal antibody that binds vascular endothelial growth factor (VEGF) to inhibit tumor angiogenesis. Administered intravenously at 7.5 mg/kg every 2 weeks in combination with RC48.
Pyrotinib
An irreversible pan-HER tyrosine kinase inhibitor targeting HER1, HER2, and HER4, inhibiting downstream PI3K/Akt and MAPK signaling. Administered orally at 320 mg once daily (post-meal) in combination with RC48.
RECRUITING
The First Affiliated Hospital with Nanjing Medical University, Nanjing
RenJi Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
The Affiliated Hospital of Xuzhou Medical University
OTHER
The First Hospital of Jilin University
OTHER
Shanghai Minhang Central Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Huai'an First People's Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER