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Esophageal Squamous Cell CarcinomaPhase 2NCT03940976

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

A Phase 2 study testing Afatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Afatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
28 Apr 2019to 1 May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital and Institute

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

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)

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.

Being tested
Afatinib
Keywords
afatinib, EGFR Overexpression, EGFR Amplification
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfatinibDrug

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

Study groups in NCT03940976
Study groupRoleWhat they receive
AfatinibExperimentalNot described
Receives: Drug: Afatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Incidence of Treatment-Related Adverse Events

    Number of adverse events of afatinib in patients with ESCC.

    Measured: Until 30 days after the last treatment

  2. Disease control rate

    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).

    Measured: 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.

  3. Progression free survival

    Measure of time from study treatment to disease progression or death

    Measured: Up to 2 years

  4. Overall survival

    Measure of time from study treatment to patient's death or lost to follow-up.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start28 Apr 2019
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 May 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03940976
Sponsor's protocol ID
ESCC-A01
Status last verified
Jun 2019
First submitted
28 Apr 2019
Last updated
11 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38937446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03940976, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.

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