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Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib Hydrochloride
Sponsored by
Yuhong Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients have provided a signed Informed Consent Form
  • Age: 18-75 years old
  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma
  • Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy
  • Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
  • Life expectancy ≥ 3 months
  • Karnofsky score ≥70

  • Patient has adequate bone marrow and organ function

    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    • Platelets ≥ 75 x 109/L
    • Hemoglobin ≥ 9.0 g/dL

  • Patient has adequate liver function

    • AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
    • Serum bilirubin ≤ 2 x ULN
  • Creatinine ≤ 1.5 times ULN
  • No malabsorption or other gastrointestinal disorders affecting drug absorption.
  • No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.
  • Expect good compliance

Exclusion Criteria:

  • Patient has received previous treatment with EGFR inhibitors
  • Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing
  • Known severe hypersensitivity to Icotinib or any of the excipients of this product
  • CNS metastases without radiotherapy and/or surgery
  • Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks
  • Evidence of clinically active Interstitial Lung Diseases
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases
  • Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
  • psychiatric illness that would prevent the patient from giving informed consent
  • Patient is concurrently using other approved or investigational antineoplastic agent
  • Pregnant or lactating women

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib Hydrochloride

Arm Description

Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.

Outcomes

Primary Outcome Measures

Disease control rate
Disease control rate of tumor

Secondary Outcome Measures

Overall survival
From time of diagnosis to death or lost to follow-up
Time to progression
From time of diagnosis to disease progression
Adverse event
Safety data will be assessed at each study visit using NCI CTCAE version 3.0
EORTC QLQ-C30 and QLQ-OES18
Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18

Full Information

First Posted
October 25, 2013
Last Updated
February 14, 2023
Sponsor
Yuhong Li
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1. Study Identification

Unique Protocol Identification Number
NCT01973725
Brief Title
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
Official Title
PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuhong Li

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
Detailed Description
Currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.More effective therapy for patients with this disease who developed disease progression after first line therapy is needed.Although Erlotinib is recommended in NCCN Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icotinib Hydrochloride
Arm Type
Experimental
Arm Description
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Icotinib Hydrochloride
Other Intervention Name(s)
Conmana
Intervention Description
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Primary Outcome Measure Information:
Title
Disease control rate
Description
Disease control rate of tumor
Time Frame
for up to 6 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
From time of diagnosis to death or lost to follow-up
Time Frame
Time from day 1 to date of death
Title
Time to progression
Description
From time of diagnosis to disease progression
Time Frame
Time from day 1 to date of documented disease progression
Title
Adverse event
Description
Safety data will be assessed at each study visit using NCI CTCAE version 3.0
Time Frame
Each follow up vist, assessed up to 12 months
Title
EORTC QLQ-C30 and QLQ-OES18
Description
Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18
Time Frame
Time from day 1 to date of death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have provided a signed Informed Consent Form Age: 18-75 years old Histologically confirmed diagnosis of esophageal squamous cell carcinoma Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria Life expectancy ≥ 3 months Karnofsky score ≥70 Patient has adequate bone marrow and organ function Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelets ≥ 75 x 109/L Hemoglobin ≥ 9.0 g/dL Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 2 x ULN Creatinine ≤ 1.5 times ULN No malabsorption or other gastrointestinal disorders affecting drug absorption. No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃. Expect good compliance Exclusion Criteria: Patient has received previous treatment with EGFR inhibitors Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing Known severe hypersensitivity to Icotinib or any of the excipients of this product CNS metastases without radiotherapy and/or surgery Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks Evidence of clinically active Interstitial Lung Diseases Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ psychiatric illness that would prevent the patient from giving informed consent Patient is concurrently using other approved or investigational antineoplastic agent Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yuhong, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

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