Gastric carcinoma
Conditions
Interventions
experimental group:docetaxel plus oxaliplatin and capecitabine
control group:oxaliplatin plus capecitabine
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have signed the informed consent and are able to follow the visit and related procedures specified in the plan. 2. Aged >= 18 years and = 4 x 10^9/L, platelet >= 100 x 10^9/L without blood transfusion, neutrophil absolute value (ANC) >= 1.5 x 10^9/L without granulocyte stimulating factor treatment, and hemoglobin >= 90 g/L. 7. Bilirubin 45 ml/min; 9. Serum albumin >= 25 g/L (2.5g /dL); 10. INR or PT <= 1.5 times ULN; 11. Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA virus quantitative detection, only < the upper limit of the normal detection value can be included in the group, and should long-term use of anti-hepatitis b drugs; 12. Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing.
Exclusion criteria
Exclusion criteria: 1. Patients with poor wound healing after operation who are not suitable to start chemotherapy; 2. Patients with recurrence or suspected peritoneal metastasis after radical operation; 3. Patients with known DPD deficiency; 4. Patients who are allergic to, have a history of severe allergy to, or have contraindications to, any investigational drug or its excipients; 5. Patients who are expected to require major surgery during the study period; 6. With congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia; 7. With tested positive for HIV; 8. With active hepatitis b or c; 9. Only liquid diet was allowed after the operation, with BMI = NCI CTCAE grade 2; 19. Serum albumin < 2.5 g/dL; 20. With chronic enteritis; 21. With any other disease for which there is evidence of a need to limit the use of experimental drugs; 22. Patients who participated in other trials or planned to participate in other trials within 30 days before the start of the trial; 23. Patients who received other investigational drugs within 28 days before the start of the trial; 24. Women who are pregnant or nursing, or who plan to become pregnant within five months of the end of treatment. Women of childbearing age should receive a blood/urine pregnancy test 7 days before the start of the trial; 25. Patients with clinically significant active bleeding; 26. Patients who have trouble swallowing tablets; 27. With previous allogeneic bone marrow transplant or organ transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);Adverse reaction;Quality of Life (QOL); | — |
Countries
China
Contacts
Public ContactSuxia Luo /Ning Li
He'nan Cancer Hospital
Outcome results
None listed