TRASTUZUMAB for Esophageal squamous cell carcinoma|Esophageal cancer

Inclusion criteria

• {"criterion_text":"- 1. Signed informed consent\n- 2. Age ≥18 years\n- Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy\n- HER2 positive defined as either: a. IHC1+ and ISH positive (amplification ratio (HER2/CEP17) ≥ 2.0) and a high gene count fulfilling either: (HER2/cell) ≥ 6.0 or (HER2/cell) ≥ 4.0 assessed by two different ISH probes b. IHC2+ and ISH positive (ISH amplification ratio (HER2/CEP17) ≥ 2.0) c. IHC3+\n- ECOG PS <2\n- Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA\n- Adequate bone marrow function and organ function: a. Leucocytes > 3.0 x 109/l, neutrocytes > 1.5 x 109/l and thrombocytes > 100 x 109/l b. Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases). c. Creatinine clearance > 30 ml/min"}

Exclusion criteria

• {"criterion_text":"- Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed\n- Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed\n- Pregnancy or breast-feeding\n- Positive serum pregnancy test in women of childbearing potential\n- Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study\n- 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\n- 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.\n- Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n- Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients\n- Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis\n- 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.\n- 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\n- Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis."}

Primary endpoints

• {"endpoint_text":"- If response in 12 out of 24 patients, the alternative hypothesis is accepted, and the drug is considered appropriate for further evaluation.","definition_or_measurement_approach":"Decision rule: If response in 12 out of 24 patients, the alternative hypothesis is accepted and the drug is considered appropriate for further evaluation. Main objective states efficacy determined by 6 months progression free survival (PFS) assessed by RECIST 1.1."}

Denmark

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

09-01-2025

Processing Time Days

45

Number Of Sites

4

Number Of Participants

24

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"OmicVision Biosciences ApS","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}