Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-08-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type PROCEDURE

After entering the group subject receive Cryotherapy on lung cancer

Icotinib

Intervention Type DRUG

After Cryotherapy, subjects begin Icotinib administration

Interventions

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Cryotherapy

After entering the group subject receive Cryotherapy on lung cancer

Intervention Type PROCEDURE

Icotinib

After Cryotherapy, subjects begin Icotinib administration

Intervention Type DRUG

Other Intervention Names

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Cryoablation EGFR-TKI

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No