Last updated: October 8, 2019
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Not Recruiting
Phase
2
Condition
Gastric Cancer
Adenocarcinoma
Gastric Ulcers
Treatment
N/AClinical Study ID
NCT04121039
FNF016
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of thegastric or gastroesophageal junction. No previous treatment with chemotherapy or radiation therapy. Ability to take medicationsorally. With measurable lesions. Patients must have a performance status of 0-1 on theEastern Cooperative Oncology Group (ECOG) scale. Without serious system dysfunction and could tolerate chemotherapy. With normal marrow,liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a totalbilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; acreatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT)and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis. Life expectancy ≥3 months. With normal electrocardiogram results and no history ofcongestive heart failure. Without bleeding and thrombosis disease. With normal coagulation function: activatedpartial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN. Female subjects of child-bearing potential must agree to use contraceptive measuresstarting 1 week before the administration of the first dose of apatinib until 8 weeks afterdiscontinuing study drug. Male subjects must agree to use contraceptive measures during thestudy and 8 weeks after last dose of study drug With written informed consent signedvoluntarily by patients themselves or their supervisors witted by doctors. With good compliance and agree to accept follow-up of disease progression and adverseevents.
Exclusion
Exclusion Criteria:
- Patients with a history of another neoplastic disease within the past three years,excluding basal cell carcinoma of the skin, cervical carcinoma in situ, ornonmetastatic prostate cancer. Patients with brain or central nervous system metastases, including leptomeningeal disease. Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound, ulcer, orbone fracture. Significant cardiac disease as defined as: unstable angina, New York HeartAssociation (NYHA) grade II or greater, congestive heart failure, history of myocardialinfarction within 6 months Evidence of bleeding diathesis or coagulopathy. History of a stroke or CVA within 6 months. Clinically significant peripheral vasculardisease. Inability to comply with study and/or follow-up procedures. Patients with anyother medical condition or reason, in that investigator's opinion, makes the patientunstable to participate in a clinical trial.
Study Design
Total Participants: 116
Study Start date:
December 01, 2019
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Rongbo Lin
Fuzhou, Fujian 350014
ChinaSite Not Available

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