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Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Afatinib

Toripalimab

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring afatinib, toripalimab, EGFR Overexpression, EGFR Amplification

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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:

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
Contraindications of afatinib.
Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
Gastrointestinal perforation and/or fistula occurred within 3 months before enrollment
Patients with active autoimmune disease or stable disease with high risk of recurrence
Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment
Live vaccine was injected within 4 weeks before enrollment
Previously received treatment with EFFR-TKI

Sites / Locations

Peking University Cancer Hospital and Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Afatinib plus toripalimab

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate

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

Secondary Outcome Measures

Duration of response

Measure of time from first response to disease progression or death

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).

Incidence of Treatment-Related Adverse Events

Number of adverse events.

Progression free survival

Measure of time from study treatment to disease progression or death.

Overall survival

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

Full Information

NCT ID

NCT04880811

First Posted

May 6, 2021

Last Updated

July 11, 2021

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT04880811

Brief Title

Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 2021 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

afatinib, toripalimab, EGFR Overexpression, EGFR Amplification

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Afatinib plus toripalimab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Afatinib

Intervention Description

Afatinib is orally administered at 40mg Qd of each 21 day cycle.

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Intervention Description

Toripalimab is given by intravenous infusion at 200mg d1 of each 21 day cycle.

Primary Outcome Measure Information:

Title

Objective response rate

Description

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

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.

Secondary Outcome Measure Information:

Title

Duration of response

Description

Measure of time from first response to disease progression or death

Time Frame

Up to 2 years

Title

Disease control rate

Description

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).

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.

Title

Incidence of Treatment-Related Adverse Events

Description

Number of adverse events.

Time Frame

Until 30 days after the last treatment

Title

Progression free survival

Description

Measure of time from study treatment to disease progression or death.

Time Frame

Up to 2 years

Title

Overall survival

Description

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

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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) No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃. Good compliance 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. Pregnancy or lactation period. Active severe infection within 14 days Contraindications of afatinib. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding Gastrointestinal perforation and/or fistula occurred within 3 months before enrollment Patients with active autoimmune disease or stable disease with high risk of recurrence Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment Live vaccine was injected within 4 weeks before enrollment Previously received treatment with EFFR-TKI

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Shen, Professor

Phone

86-10-88196561

linshenpku@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhihao Lu, Professor

Phone

86-10-88196561

13810549767@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Shen, Professor

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital and Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification

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