A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
1. Disease specific inclusion criteria:
- Histologically documented gastricadenocarcinoma with Lauren classification
Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and
- Measurable disease is required
- Karnofsky score 80%.
- Physical condition and adequate organ function to ensure the success of abdominal
- Life expectancy ≥12 weeks.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 ×
109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 ×
upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence
of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper
limit of normal (ULN); ALB ≥30g/L.
Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60
- Female subjects should not be pregnant or breast-feeding.
- No serious concomitant disease that will threaten the survival of patients to less
than 5 years.
2. General inclusion criteria:
- Male or female. Age ≥ 18 years and ≤75 years
- Written (signed) informed consent.
- Able to comply with study and follow-up procedures.
- Good compliance with the treatment plan。
- Consent to provide tissue sample。
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the response rate of XELOX in the neoadjuvant setting of LAGC
the response rate evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after)., brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
6 months after the last subject participating in
Tianshu Liu, Doctor
Medical oncology Shanghai zhongshan hospital
United States: Food and Drug Administration