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Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

Primary Purpose

Lung Neoplasms

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cryotherapy

Icotinib

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Lung Neoplasms, EGFR mutation, Cryotherapy, Icotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction.

Outcomes

Primary Outcome Measures

progression-free survival

the time that subjects reach their disease progress

Secondary Outcome Measures

overall survival

the time subjects die

Full Information

NCT ID

NCT02744664

First Posted

April 11, 2016

Last Updated

May 24, 2020

Sponsor

Fuda Cancer Hospital, Guangzhou

1. Study Identification

Unique Protocol Identification Number

NCT02744664

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

August 15, 2017 (Actual)

Study Completion Date

August 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

Keywords

Lung Neoplasms, EGFR mutation, Cryotherapy, Icotinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction.

Intervention Type

Procedure

Intervention Name(s)

Cryotherapy

Other Intervention Name(s)

Cryoablation

Intervention Description

After entering the group subject receive Cryotherapy on lung cancer

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

EGFR-TKI

Intervention Description

After Cryotherapy, subjects begin Icotinib administration

Primary Outcome Measure Information:

Title

progression-free survival

Description

the time that subjects reach their disease progress

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

overall survival

Description

the time subjects die

Time Frame

3-3.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lizhi Liu, M.D.

Organizational Affiliation

Fuda Cancer Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25651787

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.

Results Reference

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PubMed Identifier

17008692

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.

Results Reference

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PubMed Identifier

23911808

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.

Results Reference

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PubMed Identifier

23948351

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.

Results Reference

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Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

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