The Safety and Efficacy of Neoadjuvant Chemotherapy using Apatinib plus SOX in Local Advanced Gastric Cancer

• Register: ChiCTR
• Last refreshed on: 22 July 2019
• Main ID: ChiCTR-OPC-16010061
• Date of registration: 2016-12-01
• Prospective Registration: Yes
• Primary sponsor: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
• Public title: The Safety and Efficacy of Neoadjuvant Chemotherapy using Apatinib plus SOX in Local Advanced Gastric Cancer
• Scientific title: The Safety and Efficacy of Neoadjuvant Chemotherapy using Apatinib plus SOX in Local Advanced Gastric Cancer
• Date of first enrolment: 2016-12-02
• Target sample size: Apatinib plus SOX group:29;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=16870
• Study type: Interventional study
• Study design: Non randomized control
• Phase: 2

Countries of recruitment

China

Contacts

• Name: Li Chen
• Affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

• Name: Zhu Zhenggang
• Affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Key inclusion & exclusion 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, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and Endogenous creatinine clearance >50ml/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: 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.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Apatinib plus SOX group:Apatinib+Tegafur+Oxaliplatin;

Primary Outcome(s)

Pathologic response rate;

Secondary Outcome(s)

the rate of R0;DCR;ORR;Downstaging;safety;

Source(s) of Monetary Support

self-finacing

Ethics review

Status: Approved
Approval date: 15/11/2016
Contact:

Yang Weiguo

[phone]