drugset
drugset / Trial / NCT07108127

Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer

NCT07108127 ↗

Phase 2 Recruiting 24 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the complete response rate (CR) of trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine in neoadjuvant treatment of patients with locally advanced (cT3/T4, N+, distance from the lower edge of the tumor to the anal verge ≤12 cm) HER2-positive rectal adenocarcinoma.

Timeline

Start
2025-06-20
Primary completion
2026-12-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody — —
Subject Trastuzumab Monoclonal antibody — —
Background Capecitabine Small molecule — —
Background Oxaliplatin Small molecule — —

Indications

rectum adenocarcinoma