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

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.

Trial Details

NCT ID

NCT07108127

Phase

PHASE2

Sponsor

Peking Union Medical College Hospital

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX

Locations (sample)

Beijing, China|39.9075,116.39723

Key Eligibility Criteria

Age ≥ 18 years old;
Patients with rectal cancer confirmed by histology or cytology; locally advanced (cT3/T4, N+, distance from the lower edge of the tumor to the anal…
HER2 positive after detection: HER2 positive is defined as IHC test result 3+, or IHC test result 2+ and FISH method confirms positive HER2 gene am…
Tumor tissue gene test RAS/BRAF is wild type (previous test results are acceptable);

For full eligibility, visit ClinicalTrials.gov.

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