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

NCT04880811 | Unknown Phase 2

• 1 other identifier: ESCC-AT
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

afatinib; toripalimab; 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 (5)

• 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.

• 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

Study Arms (1)

Afatinib plus toripalimab

EXPERIMENTAL

Drug: Afatinib; Drug: Toripalimab

Interventions

Afatinib DRUG

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

Afatinib plus toripalimab

Toripalimab DRUG

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

Afatinib plus toripalimab

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:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Afatinib; toripalimab

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 & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, Professor

CONTACT

86-10-88196561; linshenpku@163.com

Zhihao Lu, Professor

CONTACT

86-10-88196561; 13810549767@126.com

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: May 6, 2021
• First Posted: May 11, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)