Clinical trial: Study of Anlotinib in Patients With Gastric Cancer(ALTER0503) (NCT02461407)

Eligibility criteria:
Inclusion Criteria:

          1. Signed and dated informed consent;

          2. Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal
             junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)

          3. Advanced stomach cancer patients who have failed to the second line or higher line
             chemotherapy treatment

          4. >=18 years old；ECOG PS：0~1；Estimated life expectancy >3 months

          5. Main organs function is normal;

        Exclusion Criteria:

          1. Patients who have been treated with anlotinib previously;

          2. Patients who have been treated with other VEGFR-TKI small-molecule drugs previously,
             such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect

          3. Patients suffering from other malignancies currently or within 5 years, except for
             cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder
             cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma
             invasion into lamina propria) ]

          4. Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this
             study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or
             received mitomycin C within 6 weeks before this study). Extended field
             radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field
             radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;

          5. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous
             treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by
             oxaliplatin;

          6. Patients with a clear tendency of gastrointestinal bleeding;

          7. Patients with factors that could affect oral medication (such as dysphagia，chronic
             diarrhea etc.)

          8. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2
             or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount
             of activities, affecting Instrumental activities of daily life])

          9. Patients with any severe and/or unable to control diseases;

         10. Patients underwent major surgical treatment，open biopsy or significant traumatic
             injury within 28 days prior to assignment;

         11. Patients with any physical signs of bleeding diathesis or medical history, no matter
             how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events
             occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers
             or fractures;

         12. Patients with arterial or venous thromboembolic events occurred within 6 months, such
             as cerebrovascular accident (including transient ischemic attack), deep vein
             thrombosis and pulmonary embolism;

         13. Patients with drug abuse history and unable to get rid of or Patients with mental
             disorders

         14. Brain metastases patients with symptoms or symptoms controlled < 2 months;

         15. Patients participated in other anticancer drug clinical trials within 4 weeks or
             Patients participating in other clinical trials now;
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.


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