Preliminary Evaluation of Safety and Efficacy by [14C] AC0010 Trail and Subsequent AC0010 Treatment

Exclusion Criteria

• •Prior treated with AC0010 or allergic to drug or its formulation ingredients
• •Patients receiving other anti-tumor therapy
• •Impairment of GI disease, renal disorders or liver disease that may significantly alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction)
• •HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers positive and receiving anti-virus drugs
• •Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received hormones or mannitol for the brain metastasis
• •Previous EGFR-TKI treatment related Interstitial lung disease history
• •Known human immunodeficiency virus infection (HIV), other acquired or congenital immunodeficiency disease, or a history of organ transplantation
• •Any severe and / or uncontrolled active infections
• •Patients receiving concomitant immunosuppressive agents or high-dose corticosteroids
• •Any severe and / or uncontrolled medical conditions
• •Patients being treated with drugs recognized as being inhibitors or inducers of the liver isoenzyme in the last 4 weeks prior to registration in the current study
• •Within 3 days prior to the treatment taking of dragon fruit, pomelo, grapefruit, orange, mango and other fruit may affect drug metabolizing enzymes or juice
• •Major surgery, incisional biopsy or traumatic injuries;
• •Within 4 weeks prior to the screening patients with bleeding ≥ grade 3, non-healing wound, sever ulcer or bone fracture
• •Patients received high dose irradiation treatment or other 14C-labeled drug within 1 year
• •Known a history of alcoholism or drug abuse
• •Investigator judgment that patient is unsuitable to participate in study