Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)
NCT ID: NCT03940976
Last Updated: 2019-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2019-04-28
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Afatinib
Afatinib
Afatinib is orally administered at 40mg Qd of each 28 day cycle.
Interventions
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Afatinib
Afatinib is orally administered at 40mg Qd of each 28 day cycle.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 to 70 years old.
3. Histologically confirmed esophageal squamous carcinoma
4. Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
5. Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
6. Refractory or intolerant to at least one regimen.
7. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
8. Life expectancy of ≥3 month
9. Eastern Cooperative Oncology Group (ECOG) 0-2
10. WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.5 times ULN，Serum creatinine \<1.5 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
11. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃.
12. Good compliance
Exclusion Criteria
2. Unable to take afatinib orally because of esophageal stenosis.
3. Currently receiving other effective regimens.
4. Previous anticipate other clinical trial within 4 weeks before entering this study.
5. No measurable lesions, eg. pleural fluid and ascites.
6. With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
7. Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
8. Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
9. HIV infection, active hepatitis B or hepatitis C.
10. Unstable systemic diseases such as poorly controlled diabetes.
11. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
12. Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
13. Pregnancy or lactation period.
14. Active severe infection within 14 days.
18 Years
70 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Shen Lin
Clinical Professor
Principal Investigators
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Lin Shen, Professor
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital and Institute
Locations
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Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China
Countries
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References
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Wang Y, Liu C, Chen H, Jiao X, Wang Y, Cao Y, Li J, Zhang X, Sun Y, Zhuo N, Dong F, Gao M, Wang F, Dong L, Gong J, Sun T, Zhu W, Zhang H, Shen L, Lu Z. Clinical efficacy and identification of factors confer resistance to afatinib (tyrosine kinase inhibitor) in EGFR-overexpressing esophageal squamous cell carcinoma. Signal Transduct Target Ther. 2024 Jun 28;9(1):153. doi: 10.1038/s41392-024-01875-4.
Other Identifiers
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ESCC-A01
Identifier Type: -
Identifier Source: org_study_id
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