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HERES trial: Trastuzumab and standard treatment with chemo- and immunotherapy as first line treatment for HER2 positive esophageal squamous cell carcinoma patients
EU CTIS ID: 2024-516318-40-02
What this study is testing
To determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with ESCC determined by 6 months progression free survival (PFS) (RECIST 1.1).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed informed consent
- 2. Age ≥18 years
- Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
- 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+
- ECOG PS <2
- Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA
You likely can't join if
- Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
- Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed
- Pregnancy or breast-feeding
- Positive serum pregnancy test in women of childbearing potential
- Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study
- 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
See the full eligibility criteria
- 1. Signed informed consent
- 2. Age ≥18 years
- Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
- 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+
- ECOG PS <2
- Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA
- 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
- Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
- Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed
- Pregnancy or breast-feeding
- Positive serum pregnancy test in women of childbearing potential
- Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study
- 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
- 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.
- Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients
- Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis
- 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.
- 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
- Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.