Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT02558959
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-10', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'within 1 year', 'description': 'PFS'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'within 1 year', 'description': 'OS'}]}, 'conditionsModule': {'conditions': ['Biliary Tract Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin\n* Age 18 years or older\n* Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)\n* Karnofsky performance status (KPS) of at least 70%\n* Adequate renal function, adequate hepatic function, adequate bone marrow function\n\nExclusion Criteria:\n\n* The presence of any severe concomitant disease that could interrupt the planned treatment\n* Intractable pain\n* Hypersensitivity to study drugs\n* Serious cardiovascular disease\n* If female, pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02558959', 'briefTitle': 'Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ZYYYMedOncoBIL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan and Capecitabine', 'description': 'irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w', 'interventionNames': ['Drug: Irinotecan', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Irinotecan', 'description': 'irinotecan 180mg/m2 d1, q2w', 'interventionNames': ['Drug: Irinotecan']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'armGroupLabels': ['Irinotecan', 'Irinotecan and Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'armGroupLabels': ['Irinotecan and Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First affiliated hospital, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cancer Biotherapy Center', 'investigatorFullName': 'Weijia Fang', 'investigatorAffiliation': 'Zhejiang University'}}}}