Clinical trial: The FLOT Regimen Conversion Therapy of Adenocarcinoma of the Stomach / Gastroesophageal (NCT03451942)

Eligibility criteria:
Inclusion Criteria:

          1. Patients volunteered to participate in this study and signed informed consent.

          2. Endoscopic biopsy or metastatic biopsy was confirmed to be the adenocarcinoma of the
             stomach / gastroesophageal.

          3. Her - 2 negative(Including: Her protein detection -/1+, and Her protein 2+ but FISH
             negative).

          4. Without any antitumor therapy;

          5. According to the 7th edition of AJCC, imaging (CT/MRI) confirmed that the
             adenocarcinoma of the stomach / gastroesophageal with the initial single site
             metastasis had a detectable lesion (according to the RECIST 1.1 standard); Single site
             metastasis includes: liver, spleen, pancreas, ovary, retroperitoneal lymph node
             (16a1/b2), adrenal gland, kidney;

          6. Age from 18 to 70 years.

          7. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.

          8. Life expectancy more than 12 weeks.

          9. Histological specimens were provided for biological target detection of her-2;

         10. Surgical patients agree to undergo surgery and sign an informed consent to perform the
             risk of surgery；

         11. The main organ function meet the following criteria within 7 days before treatment:

               -  blood routine examination( No blood transfusion within 14 days)

                    1. HB≥90g/L，

                    2. ANC≥1.5×109/L，

                    3. PLT≥80×109/L；

               -  blood biochemical examination

                    1. TBIL <1.5 Upper Limit Of Normal（ULN）;

                    2. ALT and AST<2.5ULN(or ≤ 5×ULN in patients with liver metastases).

                    3. Cr≤1.5ULN or creatinine clearance>60ml/min.

               -  Doppler ultrasonography: left ventricular ejection fraction (LVEF) was lower than
                  normal (50%).

         12. Female subjects of child-bearing potential should agree to use contraceptive measures
             (such as intrauterine contraceptives, contraceptives or condoms) within six months of
             the study period and the end of the study. The serum or urine pregnancy test was
             negative within 7 days prior to the study and must be non-lactation. Men subjects
             should agree to use contraceptives in the study period and within six months at the
             end of the study period.

        Exclusion Criteria:

          1. 5 years or at the same time have other malignant tumors；

          2. docetaxel or oxaliplatin and other research with chemotherapy drugs are serious
             allergy;

          3. patients with severe cachexia can not eat and can not tolerate chemotherapy and
             surgery;

          4. During the screening period, there was an unknown cause of fever before the first
             administration and the body temperature was> 38.5 ° C (as judged by the investigators,
             cancer-related fever subjects could be enrolled);

          5. Patients with any severe and / or uncontrollable disease, including:

               1. Patients with hypertension who are not well controlled by antihypertensive
                  medication (systolic BP ≥150 mmHg, diastolic BP ≥100 mmHg);

               2. Myocardial ischemia or myocardial infarction with grade I or above, arrhythmia
                  (including QTc≥480 ms) and ≥2 grade congestive heart failure (New York Heart
                  Association (NYHA) classification);

               3. Severe infection that is active or uncontrollable (≥CTCAE grade 2 infection);

               4. Renal failure requires hemodialysis or peritoneal dialysis;

               5. Have a history of immunodeficiency, including HIV-positive or other acquired,
                  congenital immunodeficiency disease, or history of organ transplants;

               6. Poor glycemic control in diabetic patients (fasting blood glucose (FBG)> 10 mmol
                  / L);

               7. Patients with seizures who require treatment;

          6. Currently there are gastrointestinal diseases such as intestinal obstruction
             (including incomplete intestinal obstruction) or the researchers determine the
             patients may cause gastrointestinal bleeding, perforation or obstruction;

          7. Within 4 weeks prior to enrollment, there were non-healing wounds, ulcers or
             fractures;

          8. CNS metastasis;

          9. Persons with psychiatric abuse who can not be abdicated or have mental disorders;

         10. patients who have participated in other anti-cancer drug clinical trials within 4
             weeks;

         11. According to the judgment of the researcher, there is a concomitant disease which
             seriously endangers the safety of the patient or affects the patient in completing the
             study.
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 70 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