Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03940976

Collaborator

(none)

Enrollment

Location

Arm

12.1

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2 trial investigating the effect and safety of afatinib in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: Afatinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Afatinib in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification (ESCC-A01)

Actual Study Start Date :

Apr 28, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afatinib	Drug: Afatinib Afatinib is orally administered at 40mg Qd of each 28 day cycle.

Arm

Intervention/Treatment

Experimental: Afatinib

Drug: Afatinib

Afatinib is orally administered at 40mg Qd of each 28 day cycle.

Outcome Measures

Primary Outcome Measures

Objective response rate [From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.]
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

Secondary Outcome Measures

Incidence of Treatment-Related Adverse Events [Until 30 days after the last treatment]
Number of adverse events of afatinib in patients with ESCC.
Disease control rate [From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.]
Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Progression free survival [Up to 2 years]
Measure of time from study treatment to disease progression or death
Overall survival [Up to 2 years]
Measure of time from study treatment to patient's death or lost to follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having signed informed consent.
Age 18 to 70 years old.
Histologically confirmed esophageal squamous carcinoma
Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
Refractory or intolerant to at least one regimen.
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)
Life expectancy of ≥3 month
Eastern Cooperative Oncology Group (ECOG) 0-2
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)
No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.
Good compliance

Exclusion Criteria:

Contraindications of afatinib.
Unable to take afatinib orally because of esophageal stenosis.
Currently receiving other effective regimens.
Previous anticipate other clinical trial within 4 weeks before entering this study.
No measurable lesions, eg. pleural fluid and ascites.
With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
HIV infection, active hepatitis B or hepatitis C.
Unstable systemic diseases such as poorly controlled diabetes.
Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
Pregnancy or lactation period.
Active severe infection within 14 days.