Clinical trial: A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer (NCT04351867)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment