Cryotherapy Combine Icotinib for Advanced NSCLC Treatment

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 4

Conditions: Lung Neoplasms

Treatments: Drug: Icotinib; Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02744664

FUDA2016004

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental

Experimental group

Description:

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

Treatment:

Procedure: Cryotherapy

Drug: Icotinib