- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973725
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
February 14, 2023 updated by: Yuhong Li
PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Icotinib Hydrochloride
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
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Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate
Time Frame: for up to 6 months
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Disease control rate of tumor
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for up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Time from day 1 to date of death
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From time of diagnosis to death or lost to follow-up
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Time from day 1 to date of death
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Time to progression
Time Frame: Time from day 1 to date of documented disease progression
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From time of diagnosis to disease progression
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Time from day 1 to date of documented disease progression
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Adverse event
Time Frame: Each follow up vist, assessed up to 12 months
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Safety data will be assessed at each study visit using NCI CTCAE version 3.0
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Each follow up vist, assessed up to 12 months
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EORTC QLQ-C30 and QLQ-OES18
Time Frame: Time from day 1 to date of death
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Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18
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Time from day 1 to date of death
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Yuhong, MD, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
October 25, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (Estimate)
October 31, 2013
Study Record Updates
Last Update Posted (Actual)
February 17, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- ICO-29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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