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

NCT03940976 | Unknown Phase 2

• 1 other identifier: ESCC-A01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

afatinib; EGFR Overexpression; EGFR Amplification

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

  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.

Secondary Outcomes (4)

• Incidence of Treatment-Related Adverse Events

  Until 30 days after the last treatment

• 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.

• Progression free survival

  Up to 2 years

• Overall survival

  Up to 2 years

Study Arms (1)

Afatinib

EXPERIMENTAL

Drug: Afatinib

Interventions

Afatinib DRUG

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

Afatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

• 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.

  PMID: 38937446 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lin Shen, Professor

  Peking University Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 7, 2019
• Study Start: April 28, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)