A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

This is an interventional treatment trial for Stomach Neoplasms Read More

Inclusion Criteria:

• Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
• Age ≥18 years old and ≤75 years old
• D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
• Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
• Postoperative ECOG score was 0 or 1
• Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
• Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
• Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR>45 ml/min
• Serum albumin ≥ 25 g/L (2.5g /dL)
• INR or PT ≤ 1.5 times ULN
• 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
• Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing

Exclusion Criteria:

• Postoperative wound healing is poor and chemotherapy is not appropriate to start
• Recurrent patients or suspected peritoneal metastases after radical surgery
• Known DPD enzyme deficiency
• Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
• Patients who are expected to require major surgery during the study period
• Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
• Tested positive for HIV
• Active hepatitis b or c
• Only liquid diet was allowed after the operation, with BMI <18kg/m2
• Uncontrolled pain
• A history of antitumor drug therapy other than radical surgery
• Severe infection in the active stage or with poor clinical control
• Use of hormones is contraindicated
• Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
• Uncontrollable increase in blood pressure or blood sugar
• A history of other malignancies within 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer
• Distant metastases are known
• Peripheral neuropathy ≥ NCI CTCAE grade 2
• Serum albumin < 2.5 g/dL
• Chronic enteritis
• Any other disease for which there is evidence of a need to limit the use of experimental drugs
• Participate in additional trials up to 30 days before the trial or plan to participate in additional trials while the trial is ongoing
• Receive other experimental drugs up to 28 days before the start of the trial
• 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
• Clinically significant active bleeding
• Patients who have trouble swallowing tablets
• Previous allogeneic bone marrow transplant or organ transplant