Cryotherapy Combine Icotinib for Advanced NSCLC Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction. |
Procedure: Cryotherapy
After entering the group subject receive Cryotherapy on lung cancer
Other Names:
Drug: Icotinib
After Cryotherapy, subjects begin Icotinib administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- progression-free survival [2.5 years]
the time that subjects reach their disease progress
Secondary Outcome Measures
- overall survival [3-3.5 years]
the time subjects die
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase 3B/4;
-
Life expectancy ≥12weeks.
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Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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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.
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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.
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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.
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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:
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Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
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Allergic to Icotinib.
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Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
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Pregnancy or breast-feeding women.
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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).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fuda Cancer Hospital, Guangzhou
Investigators
- Study Chair: Lizhi Liu, M.D., Fuda Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- FUDA2016004