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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-OPC-16010061
Enrollment
Unknown
Registered
2016-12-01
Start date
2016-12-02
Completion date
Unknown
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Apatinib plus SOX group:Apatinib+Tegafur+Oxaliplatin

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Pathologic response rate;

Secondary

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

Countries

China

Contacts

Public ContactZhu Zhenggang

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

zzg1954@hotmail.com+86 18917762000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026