Phase 2 Study of Afatinib Plus Toripalimab in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification

Peking University1 site in 1 country43 target enrollmentJuly 2021

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsAfatinib Toripalimab

Overview

Phase: Phase 2
Intervention: Afatinib
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Peking University
Enrollment: 43
Locations: 1
Primary Endpoint: Objective response rate
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2021

End Date

May 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Principal Investigator

Shen Lin

Clinical Professor

Peking University Cancer Hospital & Institute

Eligibility Criteria

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)

Exclusion Criteria

•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.

Arms & Interventions

Afatinib plus toripalimab

Intervention: Afatinib

Afatinib plus toripalimab

Intervention: Toripalimab

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Incidence of Treatment-Related Adverse Events(Until 30 days after the last treatment)
Progression free survival(Up to 2 years)
Overall survival(Up to 2 years)
Duration of response(Up to 2 years)
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.)