Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT05170256
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is a two-staged single arm national phase II trial\n\n* Stage 1: 17 patients\n* Stage 2: 7 patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in amplified HER2 in ctDNA during treatment', 'timeFrame': 'During mininum 6 months follow-up', 'description': 'Clinical utility of measurements of amplified HER2 in ctDNA as a monitoring tool of treatment with 5-FU platinum, trastuzumab and pembrolizumab'}, {'measure': 'Frequency of germeline Fc Gamma Receptor polymorphisms', 'timeFrame': 'During minimum 6 months follow-up', 'description': 'Predictive value of Fc Gamma Receptor polymorphisms in ESCC patients receiving'}, {'measure': 'Frequency of PD-L1 status by CPS score', 'timeFrame': 'During minimum 6 months follow-up', 'description': 'PD-L1 status by CPS score'}], 'primaryOutcomes': [{'measure': 'Progression free survival (PFS) .', 'timeFrame': '6 months', 'description': 'PFS according to RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'Response rate according to RECIST 1.1', 'timeFrame': 'Best response during 6 months follow-up', 'description': 'Partial, complete and overall response rate according to RECIST 1.1'}, {'measure': 'Frequency of AEs assessed by NCI CTCAE, v. 5.0', 'timeFrame': 'During minimum 6 months follow-up', 'description': 'Safety and tolerability of trastuzumab, pembrolizumab and a fluoropyrimidine/platinum assessed by NCI CTCAE, v. 5.0'}, {'measure': 'Overall survival', 'timeFrame': '6 months', 'description': 'Time to death of all causes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma', 'HER-2 Protein Overexpression', 'HER-2 Gene Amplification']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥18 years\n3. Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy\n4. HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+\n5. ECOG PS \\<2\n6. Baseline left ventricular ejection fraction \\> 50% measured by echocardiography or MUGA\n7. Adequate bone marrow function and organ function:\n\n 1. Hematopoietic function:\n 2. Leucocytes \\> 3.0 x 109/l, neutrocytes \\> 1.5 x 109/l and thrombocytes \\> 100 x 109/l\n 3. Serum bilirubin \\< 1.5 × upper limit of normal (ULN); and AST/ALT \\< 2.5 × ULN (or \\< 5 × ULN in patients with liver metastases).\n8. Creatinine clearance \\> 30 ml/min\n\nExclusion Criteria:\n\n1. Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed\n2. 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\n3. 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.\n4. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n5. Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients\n6. Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis\n7. 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.\n8. 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\n9. Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis.\n10. Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed\n11. Pregnancy or breast-feeding\n12. Positive serum pregnancy test in women of childbearing potential.\n13. Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study"}, 'identificationModule': {'nctId': 'NCT05170256', 'acronym': 'HERES', 'briefTitle': 'Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'HERES Trial: Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients', 'orgStudyIdInfo': {'id': '2021-003415-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Addition of trastuzumab to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab)', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'state': 'Region H', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'solvej Thanh Le Truong, Nurse', 'role': 'CONTACT', 'email': 'solvej.thao.thanh.le.truong@regionh.dk', 'phone': '+45 3545 6329'}, {'name': 'Jon Bjerregaard, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Oncology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'state': 'Region Syd', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette Falbe-Hansen, Nurse', 'role': 'CONTACT', 'phone': '+45 29658926'}, {'name': 'Per Pfeiffer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Onkologisk Afdeling R, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Morten Mau-Sørensen, MD PhD', 'role': 'CONTACT', 'email': 'paul.morten.mau-soerensen@regionh.dk', 'phone': '35450879', 'phoneExt': '0045'}, {'name': 'Kristian Egebjerg, MD', 'role': 'CONTACT', 'email': 'kristian.egebjerg.02@regionh.dk'}], 'overallOfficials': [{'name': 'Lene Baeksgaard, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Mau-Sørensen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Morten Mau-Sørensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}