Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qun Zhao
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Capecitabine; Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically or cytologically proven in operable advanced gastric adenocarcinoma;

2. Subjects who were identified as potentially resectable cases by a multidisciplinary consultation;

3. KPS> 80; ECOG score: 0-1;

4. Expected survival> 6 months;

5. Age 20 -60;

6. Major organ function has to meet the following criteria:

Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function <1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine <1.5 × UNL, PT-INR / PTT <1.7 times the upper limit of normal;

7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria:

1. Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs;

2. History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product;

3. Receiving any form of chemotherapy or other study medication;

4. Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;

5. Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.