---
title: Cryotherapy Combine Icotinib for Advanced NSCLC Treatment
nct_id: NCT02744664
overall_status: COMPLETED
phase: PHASE4
sponsor: Fuda Cancer Hospital, Guangzhou
study_type: INTERVENTIONAL
primary_condition: Lung Neoplasms
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02744664.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02744664"
ct_last_update_post_date: 2020-05-27
last_seen_at: "2026-05-12T07:23:12.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02744664](https://clinicaltrials.gov/study/NCT02744664)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Fuda Cancer Hospital, Guangzhou
- **Conditions:** Lung Neoplasms
- **Start Date:** 2016-04-01
- **Completion Date:** 2017-08-15
- **CT.gov Last Update:** 2020-05-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **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).
```

## Arms

- **Experimental** (EXPERIMENTAL) — The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction.

## Interventions

- **Cryotherapy** (PROCEDURE) — After entering the group subject receive Cryotherapy on lung cancer
- **Icotinib** (DRUG) — After Cryotherapy, subjects begin Icotinib administration

## Primary Outcomes

- **progression-free survival** _(time frame: 2.5 years)_ — the time that subjects reach their disease progress

## Secondary Outcomes

- **overall survival** _(time frame: 3-3.5 years)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02744664.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02744664*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*