Clinical trial NCT02744664: Cryotherapy Combine Icotinib for Advanced NSCLC Treatment
Official title: A Single Arm, Open Label, Perspective Study to Determine the Efficacy and Safety of Icotinib Combine Cryotherapy for Advanced NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Neoplasms
Keywords: Lung Neoplasms
EGFR mutation
Cryotherapy
Icotinib
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: In this single arm clinical study, enrolled patients, with advanced stage NSCLC and confirmed epidermal growth factor receptor (EGFR) mutation, would receive cryotherapy for tumors and begin Icotinib, an EGFR tyrosine kinase inhibitor administration thereafter. Progression free survival, overall survival and safety wil be observed.

Eligibility 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).

Primary outcomes:
measure: progression-free survival
timeFrame: 2.5 years
Secondary outcomes:
measure: overall survival
timeFrame: 3-3.5 years
Other outcomes:
Locations:
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Liu, M.D.
role: STUDY_CHAIR
References:
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
citation: Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
citation: Zhikai Z, Lizhi N, Liang Z, Jianying Z, Fei Y, Jibing C, Jialiang L, Kecheng X. Treatment of central type lung cancer by combined cryotherapy: experiences of 47 patients. Cryobiology. 2013 Oct;67(2):225-9. doi: 10.1016/j.cryobiol.2013.07.003. Epub 2013 Jul 31.
citation: Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.