Esophageal Squamous Cell CarcinomaPhase 2HERESNCT05170256
Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
A Phase 2 study testing Trastuzumab in people with Esophageal Squamous Cell Carcinoma and HER-2 Protein Overexpression, run by Morten Mau-Sørensen at 2 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, HER-2 Protein Overexpression, HER-2 Gene Amplification
- What is being tested?
- Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- 4 Feb 2022to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age ≥18 years
- Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
- HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+
- ECOG PS <2
- Baseline left ventricular ejection fraction > 50% measured by echocardiography or MUGA
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- Adequate bone marrow function and organ function:
- Hematopoietic function:
- Leucocytes > 3.0 x 109/l, neutrocytes > 1.5 x 109/l and thrombocytes > 100 x 109/l
- Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases).
- Creatinine clearance > 30 ml/min
Who cannot join
- Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
- 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
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- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
Kristian Egebjerg, MD contact
Denmark2 sites, 2 recruiting
- Recruiting
Dept of Oncology, Rigshospitalet
Copenhagen, Region H, DK-2100
solvej Thanh Le Truong, Nurse, +45 3545 6329, solvej.thao.thanh.le.truong@regionh.dk
Jon Bjerregaard, MD PhD
- Recruiting
Onkologisk Afdeling R, Odense University Hospital
Odense, Region Syd, 5000
Mette Falbe-Hansen, Nurse, +45 29658926
Per Pfeiffer, MD PhD
About this study
Official title: HERES Trial: Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
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
- Being tested
- Trastuzumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Addition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) .
PFS according to RECIST 1.1
Measured: 6 months
Secondary outcomes (3)
Response rate according to RECIST 1.1
Partial, complete and overall response rate according to RECIST 1.1
Measured: Best response during 6 months follow-up
Frequency of AEs assessed by NCI CTCAE, v. 5.0
Safety and tolerability of trastuzumab, pembrolizumab and a fluoropyrimidine/platinum assessed by NCI CTCAE, v. 5.0
Measured: During minimum 6 months follow-up
Overall survival
Time to death of all causes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start4 Feb 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a two-staged single arm national phase II trial * Stage 1: 17 patients * Stage 2: 7 patients
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Mau-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Mau-Sørensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Baeksgaard, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170256
- Sponsor's protocol ID
- 2021-003415-26
- Acronym
- HERES
- Status last verified
- Aug 2022
- First submitted
- 24 Nov 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HERES Trial: Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05170256
- Acronym / sponsor ID
- HERES / 2021-003415-26
- Conditions
- Esophageal Squamous Cell Carcinoma, HER-2 Protein Overexpression, HER-2 Gene Amplification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Morten Mau-SørensenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a two-staged single arm national phase II trial * Stage 1: 17 patients * Stage 2: 7 patients
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- Age ≥18 years
- Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
- HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+
- ECOG PS <2
Key exclusion criteria (13 listed)
- Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAddition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) | Drug | Treatment arm |
Primary outcome
Progression free survival (PFS) .
Time frame: 6 months
PFS according to RECIST 1.1
3 secondary outcomes
Response rate according to RECIST 1.1
Time frame: Best response during 6 months follow-up
Frequency of AEs assessed by NCI CTCAE, v. 5.0
Time frame: During minimum 6 months follow-up
Overall survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Egebjerg, MD contact
Lene Baeksgaard, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab in people with Esophageal Squamous Cell Carcinoma and HER-2 Protein Overexpression, run by Morten Mau-Sørensen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Mau-Sørensen, MD PhD (35450879 ext. 0045, paul.morten.mau-soerensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.