Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients

NCT ID: NCT05170256

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2025-01-31

Brief Summary

The study aims to determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with HER2 positive Esophageal squamous cell carcinoma (ESCC) determined by 6 months progression free survival (PFS) (RECIST 1.1).

Conditions

Esophageal Squamous Cell Carcinoma; HER-2 Protein Overexpression; HER-2 Gene Amplification

Study Design

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

Study Groups

Treatment arm

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

Addition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab)

Interventions

Trastuzumab

Addition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent

2. Age ≥18 years

3. Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy

4. HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+

5. ECOG PS <2

6. Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA

7. Adequate bone marrow function and organ function:

1. Hematopoietic function:

2. Leucocytes > 3.0 x 109/l, neutrocytes > 1.5 x 109/l and thrombocytes > 100 x 109/l

3. Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases).

8. Creatinine clearance > 30 ml/min

Exclusion Criteria

1. Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed

2. Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study treatment

3. Congestive heart failure (New York Heart Association (NYHA) class 3+4); uncontrolled angina pectoris; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); or high-risk uncontrollable arrhythmias.

4. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

5. Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients

6. Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis

7. Homozygosity or compound heterozygosity for more than one gene variant of dihydropyrimidine dehydrogenase (DPD) known to cause major reduced metabolism of 5-FU derivates OR plasma uracil > 150 ng/ml are not eligible. Patients with minor DPD insufficiency are allowed provided that local guidelines for administration of 5-FU are followed.

8. Any other cancer (excluding low risk prostate cancer, carcinoma in situ and radically operated localised squamous skin cancer) with clinical activity within the last 2 years

9. Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis.

10. Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed

11. Pregnancy or breast-feeding

12. Positive serum pregnancy test in women of childbearing potential.

13. Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study

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

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Morten Mau-Sørensen

OTHER

Sponsor Role: lead

Responsible Party

Morten Mau-Sørensen

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lene Baeksgaard, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Dept of Oncology, Rigshospitalet

Copenhagen, Region H, Denmark

Site Status: RECRUITING

Onkologisk Afdeling R, Odense University Hospital

Odense, Region Syd, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Morten Mau-Sørensen, MD PhD

Role: CONTACT

paul.morten.mau-soerensen@regionh.dk

35450879 ext. 0045

Kristian Egebjerg, MD

Role: CONTACT

kristian.egebjerg.02@regionh.dk

Facility Contacts

solvej Thanh Le Truong, Nurse

Role: primary

solvej.thao.thanh.le.truong@regionh.dk

+45 3545 6329

Mette Falbe-Hansen, Nurse

Role: primary

+45 29658926

Other Identifiers

2021-003415-26

Identifier Type: -

Identifier Source: org_study_id