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Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02744664
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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
Lung Neoplasms Procedure: Cryotherapy Drug: Icotinib 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label, Perspective Study to Determine the Efficacy and Safety of Icotinib Combine Cryotherapy for Advanced NSCLC Patients
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: Cryoablation

Drug: Icotinib
After Cryotherapy, subjects begin Icotinib administration
Other Name: EGFR-TKI

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2.5 years ]
    the time that subjects reach their disease progress

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3-3.5 years ]
    the time subjects die

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02744664

Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
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Study Chair: Lizhi Liu, M.D. Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou Identifier: NCT02744664     History of Changes
Other Study ID Numbers: FUDA2016004
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Lung Neoplasms
EGFR mutation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases