Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC (NCT06023758) | Clinical Trial Compass
RecruitingPhase 2
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC
China18 participantsStarted 2023-09-22
Plain-language summary
This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
* Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consentï¼›
* Histologically or cytologically confirmed, locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
* ECOG score 0 or 1;
* Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
* Liver function met the following criteria within 7 days prior to initial administration:
Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
* Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;
* Life expectancy \>3 months;
* The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol
Exclusion Criteria:
* Existence of other active malignant tumors within 5 years or at the same time. P…