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Clinical Trial Summary

1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.

2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.

Secondary objectives:

- The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);

- percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;

- D2 resection -rate after neoadjuvant chemotherapy of XELOX;

- Overall survival;

- QOL during the whole period of treatment.

3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.

4. Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ,bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks.

5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.


Clinical Trial Description

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 resectable

- Measurable disease is required

- Karnofsky score 80%.

- Physical condition and adequate organ function to ensure the success of abdominal surgery.

- 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 ml/min.

- 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。 ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01880632
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Tianshu Liu, Doctor
Phone +861368 1973 996
Email liu.tianshu@zs-hospital.sh.cn
Status Recruiting
Phase Phase 2
Start date July 2013
Completion date August 2018

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