Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT03024450
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Based Therapy in HER2 Positive AGC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'spicimen with paraffin-embedded obtained by gastroscope or surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-21', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-16', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': '8 years', 'description': 'OS was defined as time from the beginning of first line therapy to death'}, {'measure': 'PFS', 'timeFrame': '8 years', 'description': 'PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'HER2', 'trastuzumab', 'prognosis'], 'conditions': ['Gastric Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '20728210', 'type': 'RESULT', 'citation': 'Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.'}, {'pmid': '22645475', 'type': 'RESULT', 'citation': 'Halon A, Donizy P, Biecek P, Rudno-Rudzinska J, Kielan W, Matkowski R. HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients. ScientificWorldJournal. 2012;2012:941259. doi: 10.1100/2012/941259. Epub 2012 May 3.'}, {'pmid': '22797858', 'type': 'RESULT', 'citation': 'Shitara K, Yatabe Y, Matsuo K, Sugano M, Kondo C, Takahari D, Ura T, Tajika M, Ito S, Muro K. Prognosis of patients with advanced gastric cancer by HER2 status and trastuzumab treatment. Gastric Cancer. 2013 Apr;16(2):261-7. doi: 10.1007/s10120-012-0179-9. Epub 2012 Jul 14.'}, {'pmid': '24943493', 'type': 'RESULT', 'citation': 'Gomez-Martin C, Lopez-Rios F, Aparicio J, Barriuso J, Garcia-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vazquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cancer Lett. 2014 Aug 28;351(1):30-40. doi: 10.1016/j.canlet.2014.05.019. Epub 2014 Jun 3.'}, {'pmid': '26857702', 'type': 'RESULT', 'citation': 'Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9.'}, {'pmid': '27324991', 'type': 'RESULT', 'citation': 'Jiang H, Li Q, Yu S, Yu Y, Wang Y, Li W, Cui Y, Liu T. Impact of HER2 expression on outcome in gastric cancer patients with liver metastasis. Clin Transl Oncol. 2017 Feb;19(2):197-203. doi: 10.1007/s12094-016-1523-z. Epub 2016 Jun 20.'}, {'pmid': '23430266', 'type': 'RESULT', 'citation': 'Aizawa M, Nagatsuma AK, Kitada K, Kuwata T, Fujii S, Kinoshita T, Ochiai A. Evaluation of HER2-based biology in 1,006 cases of gastric cancer in a Japanese population. Gastric Cancer. 2014 Jan;17(1):34-42. doi: 10.1007/s10120-013-0239-9. Epub 2013 Feb 22.'}, {'pmid': '29168107', 'type': 'DERIVED', 'citation': 'Li Q, Li H, Jiang H, Feng Y, Cui Y, Wang Y, Ji Y, Yu Y, Li W, Xu C, Yu S, Zhuang R, Liu T. Predictive factors of trastuzumab-based chemotherapy in HER2 positive advanced gastric cancer: a single-center prospective observational study. Clin Transl Oncol. 2018 Jun;20(6):695-702. doi: 10.1007/s12094-017-1772-5. Epub 2017 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.', 'detailedDescription': 'A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with HER2 positive advanced or metastatic gastric adenocarcinoma in Shanghai Zhongshan Hospital, Fu Dan University were prospectively collected. HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;\n2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;\n3. with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;\n4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;\n5. left ventricular ejection fraction(LVEF) more than 50 percents;\n6. sufficient bone marrow, liver and renal function.\n\nExclusion Criteria:\n\n1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);\n2. trastuzumab based adjuvant/neoadjuvant therapy;\n3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);\n4. patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.\n5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.'}, 'identificationModule': {'nctId': 'NCT03024450', 'briefTitle': 'Trastuzumab Based Therapy in HER2 Positive AGC', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ZS-ON-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2 positive AGC treated with H+CT', 'description': 'HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.', 'interventionNames': ['Drug: H+CT']}], 'interventions': [{'name': 'H+CT', 'type': 'DRUG', 'otherNames': ['trastuzumab plus chemotherapy'], 'description': 'All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.', 'armGroupLabels': ['HER2 positive AGC treated with H+CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Tianshu / Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief doctor and director of Department of medical oncology', 'investigatorFullName': 'Tianshu Liu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}