Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

• Status: Completed
• Trial end date: 2017-08-15
• Target enrollment: 0
• Participant gender: All

Summary

This trial is to designed to assess the efficacy and safety of Cryotherapy combine with Icotinib for Advanced NSCLC Patients harboring EGFR mutation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Criteria

Inclusion Criteria:

• Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase 3B/4;

• Life expectancy ≥12weeks.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• The number of target lesions in whole body ≤ 8 (and the number of lung lesions ≤ 5, the biggest one's diameter≤ 7 cm, the number of liver lesions ≤ three the biggest one's diameter ≤ 5 cm.

• Adequate hematological function: hemoglobin ≥90g/L (no blood transfusion in 14 days) Absolute neutrophil count (ANC) ≥1.5 * 109/L, and Platelet count ≥75 x 10^9/L.

• Adequate renal function: Serum creatinine ≤1.5 * upper limit of normal(ULN), or Serum creatinine≥ 50 ml/min. Adequate liver function: Total bilirubin ≤ 2 *ULN and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)< 2.5 * ULN in the absence of liver metastases, or < 5 * ULN in case of liver metastases.

• Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided.

Exclusion Criteria:

• Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

• Allergic to Icotinib.

• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

• Pregnancy or breast-feeding women.

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction with in 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).