Clinical trial: Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer (NCT02251951)

Eligibility criteria:
Inclusion Criteria:

          -  Age >18 years old

          -  Disease progression after treatment with the DCF regimen

          -  Assessable target lesion(s) as defined by RECIST criteria

          -  ECOG performance status ≤ 1

          -  Estimated life expectancy more than 3 months

          -  Serum bilirubin less than 1.5 times the upper normal limit

          -  Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper
             normal limit

          -  Creatinine Clearance ≥50 ml/min

          -  Neutrophil count more than 1.5x 109 /L

          -  Platelet count more than 100x 109 /L

          -  Hemoglobin more than 8g/dL

          -  Before patient enrollment, written informed consent must be given according to Good
             Clinical Practice guidelines and national/local regulations.

        Exclusion Criteria:

          -  Gastrointestinal bleeding

          -  Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's
             discomfort

          -  CNS metastases

          -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months
             after the end of treatment

          -  Subject (male or female) is not willing to use highly effective methods of
             contraception (per institutional standard) during treatment and for 6 months (male or
             female) after the end of treatment

          -  Known hypersensitivity reaction to the component of the treatment

          -  Active infection or malnutrition or bowel obstruction

          -  Legal incapacity or limited legal capacity

          -  Definite contraindications for the use of corticosteroids

          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
             evidence of interstitial lung disease on baseline chest CT scan

          -  Chronic inflammation of the bowel

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) ≤ 1 year before enrollment

          -  Medical or psychological condition which in the opinion of the investigator would not
             permit the subject to complete the study or sign meaningful informed consent

          -  Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


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