Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05023720
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-20', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in overall survival between the two groups calculated by Kaplan-Meier', 'timeFrame': '2021.7-2022.12', 'description': 'Survival differences between the monotherapy and combination groups'}, {'measure': 'The difference of OS in patients receiving different doses of regorafenib', 'timeFrame': '2021.11-2022.12', 'description': 'In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.'}, {'measure': 'Regorafenib in combination with other drugs', 'timeFrame': '2021.7-2022.10', 'description': 'In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Survival differences among the patients with different clinical phenotypes and genotypes', 'timeFrame': '2021.7-2022.10', 'description': 'To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic colorectal cancer', 'regorafenib'], 'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study', 'detailedDescription': 'To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n 1. Must be a pathologically proven colorectal adenocarcinoma\n 2. Must have been treated with regorafenib\n 3. Regorafenib must be used after two lines of standard antitumor therapy\n2. Exclusion Criteria:\n\n 1. Application is less than one course of treatment with regorafenib\n 2. First - or second-line treatment with regorafenib\n 3. Patients with multiple primary cancers'}, 'identificationModule': {'nctId': 'NCT05023720', 'briefTitle': 'Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study', 'orgStudyIdInfo': {'id': 'YShujun'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regorafenib group', 'description': 'Patients were given only regorafenib orally', 'interventionNames': ['Other: nonintervention']}, {'label': 'Joint group', 'description': 'The patient was treated with regorafenib orally and in combination with other medications', 'interventionNames': ['Other: nonintervention']}], 'interventions': [{'name': 'nonintervention', 'type': 'OTHER', 'armGroupLabels': ['Joint group', 'Regorafenib group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shujun Yang, bachelor', 'role': 'CONTACT'}], 'facility': 'Henan cancer hosiptal', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Shujun Yang, bachelor', 'role': 'CONTACT', 'email': 'nkyang@126.com', 'phone': '13803869419'}], 'overallOfficials': [{'name': 'Shujun Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'At any time', 'ipdSharing': 'YES', 'description': 'Clinical data of the patients', 'accessCriteria': 'Research needs'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Shujun Yang', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}