Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

A Single Arm, Open Label, Perspective Study to Determine the Efficacy and Safety of Icotinib Combine Cryotherapy for Advanced NSCLC Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02744664

Enrollment

Registered

2016-04-20

Start date

2016-04-01

Completion date

2017-08-15

Last updated

2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Lung Neoplasms, EGFR mutation, Cryotherapy, Icotinib

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.

Interventions

PROCEDURECryotherapy

After entering the group subject receive Cryotherapy on lung cancer

DRUGIcotinib

After Cryotherapy, subjects begin Icotinib administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	2.5 years	the time that subjects reach their disease progress

Secondary

Measure	Time frame	Description
overall survival	3-3.5 years	the time subjects die

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026