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

Phase II Clinical Study on the Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• HER2-positive

Interventions

Type	Name	Description
DRUG	Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX	Trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: China