Gastric Cancer
Conditions
Interventions
None listed
Sponsors
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Case of gastric cancer confirmed to be adenocarcinoma by histology or cytology. (2) Patients with age at registration of 20 years or older. (3) Case in which ECOG PS is 0 or 1. (4) Case of unresectable progressive/recurrent gastric cancer. (5) Case in which exacerbation/new lesion or recurrence was observed in the primary chemotherapy containing 5-FU drug against unresectable progressive/recurrent gastric cancer or within 16 weeks from the final administration day. (6) or cases in which recurrence was observed in the image during adjuvant chemotherapy or within 24 weeks from the last administration day. (7) A case in which adverse events due to pretreatment have recovered to CTCAE Grade 1 or lower. (8) Cases in which major organ functions are retained by clinical examination within 14 days before registration (inspection on the same day two weeks before registration date is acceptable). 1.Wte blood cell count: lower limit of facility reference value or 4,000/mm 3 or more and 12,000/mm 3 or less 2. Number of neutrophils: 2,000/ mm 3 or more 3. Platelet count: 100,000/mm 3 or more 4. Hemoglobin: 9.0 g /dL or more 5. Bilirubin in the blood: 1.5 mg/dL or less 6.AST: Standard upper limit value of medical institutions to be administered x 2.5 times or less 7. ALT: Standard limit value of medical institutions under implementationx2.5 times or less 8. Serum creatinine: 1.5 mg/ dL or less 9.reatinine clearance: 50 mL/ min or more
Exclusion criteria
Exclusion criteria: (1) Cases of squamous cell carcinoma, undifferentiated gastric cancer. (2) Consent Acknowledgment cases that underwent major surgery within 28 days before acquisition (3) Case in which chemotherapy other than platinum drugs and 5-FU drugs was administered to nonresectable progressive/recurrent gastric cancer (4) Patients who have undergone systemic chemotherapy that targeted the VEGF or VEGFR signaling pathway in the past. (5) Consent Acknowledgment cases with deep vein thrombosis, pulmonary embolism, or other serious thromboembolic disorder within 3 months before acquisition. (6) Cases receiving anticoagulant therapy such as warfarin, low molecular weight heparin (7) Cases receiving long-term administration of nonsteroidal anti-inflammatory drugs or other antiplatelet drugs (8) A patient with serious bleeding disorder or vasculitis, (9) Consent Acknowledgment cases with gastrointestinal perforation and/or fistulas within 6 months before acquisition. (10) Patients with symptomatic congestive heart failure or symptomatic or uncontrolled arrhythmia. (11) Cases with a history of arterial thromboembolism-related events, (12) Cases with arterial hypertension that can not be controlled despite standard medical management. (13) Cases with serious or unrecovered wounds, a history of peptic ulcer or bone fracture within 28 days before consent acquisition. (14) Cases with intestinal obstruction, cases with a history or complication of inflammatory bowel disease or extensive intestinal resection (15) Cases that have been treated with investigational drugs within 28 days before acquisition or scheduled to be treated with investigational drugs in the future. (16) Cases in which there is a schedule of treatment using drugs prohibited for use in this study at the time of consent acquisition. (17) Cases during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Phase I part": Determination of recommended dose (RD) for combination therapy with Nab-PTX + Ramucirumab | — |
Secondary
| Measure | Time frame |
|---|---|
| "Phase II part" Primary endpoint: treatment completion ratio at 12 weeks after starting administration | — |
Countries
Japan
Contacts
Public ContactHiroaki Tanaka
Osaka City University Graduate School of Medicine Department of Surgical Oncology,
Outcome results
None listed