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

NCT ID: NCT04880811

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afatinib plus toripalimab

Group Type: EXPERIMENTAL

Afatinib

Intervention Type: DRUG

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

Toripalimab

Intervention Type: DRUG

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

Interventions

Afatinib

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

Intervention Type: DRUG

Toripalimab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Having signed informed consent.

2. Age 18 to 70 years old.

3. Histologically confirmed esophageal squamous carcinoma

4. Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.

5. Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.

6. Refractory or intolerant to at least one regimen.

7. 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)

8. Life expectancy of ≥3 month

9. Eastern Cooperative Oncology Group (ECOG) 0-2

10. 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)

11. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.

12. Good compliance

Exclusion Criteria

1. Currently receiving other effective regimens.

2. Previous anticipate other clinical trial within 4 weeks before entering this study.

3. No measurable lesions, eg. pleural fluid and ascites.

4. With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.

5. Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.

6. Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.

7. HIV infection, active hepatitis B or hepatitis C.

8. Unstable systemic diseases such as poorly controlled diabetes.

9. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.

10. Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.

11. Pregnancy or lactation period.

12. Active severe infection within 14 days

13. Contraindications of afatinib.

14. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding

15. Gastrointestinal perforation and/or fistula occurred within 3 months before enrollment

16. Patients with active autoimmune disease or stable disease with high risk of recurrence

17. Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment

18. Live vaccine was injected within 4 weeks before enrollment

19. Previously received treatment with EFFR-TKI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Shen, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Lin Shen, Professor

Role: CONTACT

linshenpku@163.com

86-10-88196561

Zhihao Lu, Professor

Role: CONTACT

13810549767@126.com

86-10-88196561

Other Identifiers

ESCC-AT

Identifier Type: -

Identifier Source: org_study_id