Actively Recruiting
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC
Led by Peking University · Updated on 2024-05-10
18
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and agree to the informed consent
- Age between 18 and 75 years at consent
- Histologically or cytologically confirmed locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma
- ECOG performance status 0 or 1
- Left ventricular ejection fraction (LVEF) of at least 50% by ECHO or MUGA
- Liver function: total bilirubin ≤ 1.0x upper limit normal (ULN), or ≤ 1.5x ULN for Gilbert's syndrome or liver metastases; ALT/AST ≤ 1.5x ULN (or ≤ 3x ULN for liver metastases)
- Renal function: serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 60 mL/min within 7 days before treatment
- Bone marrow function: hemoglobin ≥ 90 g/L, neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, INR/PT ≤ 1.5x ULN, aPTT ≤ 1.5x ULN within 7 days before treatment
- Life expectancy greater than 3 months
- Willing and able to comply with study visits, treatments, laboratory tests, and procedures
You will not qualify if you...
- Other active cancers within 5 years or at the same time
- History of organ or bone marrow transplant or planned transplant
- Myocardial infarction or poorly controlled arrhythmias within 6 months before first dose
- Severe cardiac disorders including NYHA grade III-IV or LVEF below 50%
- HIV infection
- Active tuberculosis
- Previous or current lung diseases such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-associated pneumonia
- Prior treatment with immune checkpoint antibodies like PD-1, PD-L1, or CTLA-4 inhibitors
- Any other severe or uncontrolled acute or chronic illnesses judged by the investigator to increase risk or be unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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