Gastric Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; 2.ECOG(Eastern Cooperative Oncology Group) :0~1; 3.Definitely diagnosed gastric adenocarcinoma through Pathology or Cytology; 4.Resectable local advanced gastric cancer without distant metastasis; 5.Expected lifetime acuity >=12 months; 6.Without the history of anti-tumor therapy including Radiotherapy, chemotherapy, targeted therapy, Immunotherapy. 7.Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC>4.0*10^9/L, NE>1.5*10^9/L, PLT>100*10^9/L, Hb >= 90g/L, BIL50ml/min using Cockcroft-Gault formula. 8.Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease. 9.Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver). 10.Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. With non-removable distant metastasis; 2. In the past (5 years) or at the same time with other uncured malignant tumours except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. patients who are allergic to lapatinib or any of the ingredients in lapatinib tablets; 4. Abnormal coagulation function (INR > 1.5, ULN > 1.5 APTT), with bleeding tendency; 5. suffering from hypertension, the antihypertensive drug therapy can not be reduced to the normal range (systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg); 6. According to the investigator's judgment, there are other serious hazards to patients who are safe or affected by patients who complete the study of concomitant disease( eg Atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, renal insufficiency of urine protein test for more than 2 + ); 7. having received other drugs therapy including traditional Chinese medicine before the recruitment, or no guarantee of progress according to the study requirement after recruitment; 8. Pregnant and lactating women; 9. The researchers don't think that is suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of R0;DCR;ORR;Downstaging;safety; | — |
Countries
China
Contacts
Ruijin Hospital, Shanghai Jiaotong University School of Medicine