Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01625702
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-07', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-19', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'circulating tumor cells in blood', 'timeFrame': 'every 6 weeks'}]}, 'conditionsModule': {'keywords': ['no-prior chemotherapy'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '29178102', 'type': 'DERIVED', 'citation': 'Li Y, Peng Z, Zhang X, Gong J, Shen L. [Value of serum human epithelial growth factor receptor 2 extracellular domain and circulating tumor cells in evaluating therapeutic response in advanced gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Nov 25;20(11):1293-1299. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having signed informed consent\n* Age≥ 18 years old\n* Histologically confirmed gastric adenocarcinoma\n* Unresectable recurrent or metastatic disease\n* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months\n* Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.\n* Measurable disease according to the RECIST criteria\n* Karnofsky performance status ≥60\n* Life expectancy of ≥2 month\n* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks\n* ALT and AST\\<2.5 times ULN (≤5 times ULN in patients with liver metastases)\n* Serum albumin level ≥3.0g/dL\n* Serum AKP \\< 2.5 times ULN\n* Serum creatinine \\<ULN, and CCr \\< 60ml/min\n* Bilirubin level \\< 1.5 ULN\n* WBC\\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\\>100,000/mm3, Hb\\>9g/dl\n\nExclusion Criteria:\n\n* Brain metastasis (known or suspected)\n* Previous systemic therapy for metastatic gastric cancer\n* Inability to take oral medication\n* Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy\n* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.\n* Allergic constitution or allergic history to protium biologic product or any investigating agents.\n* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.\n* Pregnancy or lactation period\n* Any investigational agent within the past 28 days\n* Other previous malignancy within 5 year, except non-melanoma skin cancer\n* Previous adjuvant therapy with capecitabine+platinum,\n* Pre-existing neuropathy\\>grade 1\n* Legal incapacity'}, 'identificationModule': {'nctId': 'NCT01625702', 'briefTitle': 'Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'orgStudyIdInfo': {'id': 'CGOG5001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cisplatin plus capecitabine', 'description': 'gastric cancer patients treated with capecitabine/cisplatin', 'interventionNames': ['Device: CellSearch® CTC kit']}, {'type': 'EXPERIMENTAL', 'label': 'capecitabine plus paclitaxel', 'description': 'gastric cancer patients treated with capecitabine/paclitaxel', 'interventionNames': ['Device: CellSearch® CTC kit']}], 'interventions': [{'name': 'CellSearch® CTC kit', 'type': 'DEVICE', 'description': 'Collect peripheral blood sample of 100 gastric cancer patients pre-chemotherapy treated with capecitabine/paclitaxel (XPa) and capecitabine/cisplatin (XP) and post two cycles of chemotherapy(response evaluation).\n\nBlood samples will be transferred to central lab to detect CTCs by Cellsearch kit.\n\nTumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.', 'armGroupLabels': ['capecitabine plus paclitaxel', 'cisplatin plus capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of GI Oncology, Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of GI oncology', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}