OncoMatch/Clinical Trials/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
Is NCT07108127 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX for rectal cancer.
Treatment: Trastuzumab biosimilars and pertuzumab biosimilars plus XELOX — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression or amplification (IHC 3+ or IHC 2+ and FISH positive)
HER2 positive is defined as IHC test result 3+, or IHC test result 2+ and FISH method confirms positive HER2 gene amplification
Required: KRAS wild-type
Tumor tissue gene test RAS/BRAF is wild type
Required: NRAS wild-type
Tumor tissue gene test RAS/BRAF is wild type
Required: BRAF wild-type
Tumor tissue gene test RAS/BRAF is wild type
Excluded: MSH2 deficiency
Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H)
Excluded: MSH6 deficiency
Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H)
Excluded: MLH1 deficiency
Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H)
Excluded: PMS2 deficiency
Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: her2-targeted therapy
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; Hemoglobin ≥ 90g/L; Platelets ≥ 100×10^9/L; Albumin ≥ 30g/L
Kidney function
Serum creatinine ≤ 1.5×ULN and creatinine clearance > 50 mL/min (Cockcroft-Gault formula)
Liver function
Alanine aminotransferase, aspartate aminotransferase ≤ 2.5×ULN, or ≤ 5×ULN for patients with liver metastasis; Total bilirubin ≤ 1.5×ULN
Cardiac function
QTcF ≤ 450 ms at rest; NYHA heart function grade < II; LVEF ≥ 50%; no severe arrhythmias, acute coronary syndrome, or poorly controlled hypertension
Adequate organ function, laboratory tests meet the following criteria (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): ... Alanine aminotransferase, aspartate aminotransferase ≤ 2.5×ULN, alanine aminotransferase, aspartate aminotransferase ≤ 5×ULN for patients with liver metastasis; Total bilirubin ≤ 1.5×ULN; Serum creatinine ≤ 1.5×ULN and creatinine clearance > 50 mL/min (Cockcroft-Gault formula); ANC ≥ 1.5×10^9/L; Hemoglobin ≥ 90g/L; Platelets ≥ 100×10^9/L; Albumin ≥ 30g/L; QTcF ≤ 450 ms at rest; NYHA heart function grade < II; LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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