Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized,phase II,open-label study, The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their Her-2 expression status.

The primary endpoint of this study: pathology response rate the second endpoints of this study:pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Docetaxel; Oxaliplatin; Trastuzumab

Criteria

Inclusion criteria:

1. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma

2. Significant HER-2 status:

positive defined as: immunohistochemistry+ + + or FISH（fluorescence in situ hybridization） +. T negative define as: immunohistochemistry 0 ~ +, or immunohistochemistry++, and FISH negative.

3. T3-4, any N stage of gastric cancer or gastro esophageal carcinoma (seventh edition of AJCC).

4. Chemotherapy and radiotherapy naïve.

5. Aging from 18-70.

6. ECOG(Eastern Cooperative Oncology Group ) 0-1

7. Available Organ function: Neutrophils>2g/L， Hemoglobin >9g/L， Blood platelet >100g/L； Alanine aminotransferase（ALT） and Aspartate aminotransferase( AST) <1.5 ULN(upper limit of normal )； Total bilirubin(TBIL)<1.0 ULN; Cr <1.0 ULN

8. Left ventricular ejection fraction>50%

9. Written informed consent.

Exclusion criteria:

1. Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma

2. History of allergies to drugs in the study

3. Intraperitoneal dissemination or distant metastasis

4. Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites

5. Dysphagia

6. Any cause of cirrhosis

7. Cardiac function NYHA(New York Heart Association) >I degrees

8. Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia

9. Any surgical contraindication

10. Any chemotherapy or radiotherapy history

11. Any surgical resection history of gastric cancer

12. History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix

13. Any contraindication for chemotherapy