Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT03966456
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2019-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Study of Four PD-1 Agents in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-26', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-26', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PFS', 'timeFrame': '2 years', 'description': 'PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.'}], 'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '1 year', 'description': 'ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': '1 year', 'description': 'Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Cancer', 'Gynecologic Cancer', 'Abdomen Tumors', 'Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.', 'detailedDescription': 'Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. ORR will be studied of the four PD-1 agents（nivolumab, pembrolizumab, toripalimab, sintilimab）'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lung cancer, liver cancer and other solid cancers\n* Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents\n* At least one measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function\n\nExclusion Criteria:\n\n* patients treated with PD-1 agents less than 2 terms'}, 'identificationModule': {'nctId': 'NCT03966456', 'briefTitle': 'Real World Study of Four PD-1 Agents in China', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China', 'orgStudyIdInfo': {'id': 'Ic-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nivolumab', 'description': 'Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'pembrolizumab', 'description': 'Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'toripalimab', 'description': 'Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'sintilimab', 'description': 'Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['targeting therapy'], 'description': 'compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.', 'armGroupLabels': ['nivolumab', 'pembrolizumab', 'sintilimab', 'toripalimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaochun Zhang, Dr', 'role': 'CONTACT', 'email': 'jasmanouc@163.com', 'phone': '+86-532-82915333'}, {'name': 'Man Jiang, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Xiaochun Zhang, Dr', 'role': 'CONTACT', 'email': 'jasmanouc@163.com', 'phone': '+86-532-82915333'}, {'name': 'Man Jiang, Dr', 'role': 'CONTACT', 'email': 'jm_ouc@163.com', 'phone': '+86-532-82915333'}], 'overallOfficials': [{'name': 'Xiaochun Zhang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Qingdao University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD only shared in the study group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cancer Precision Medical Center', 'investigatorFullName': 'zhangxiaochun', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}