Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 2:52 PM
Study NCT ID:
NCT04487704
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Camrelizumab Utilization on Patients With Advanced Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess Safety as defined by the NCI CTCAE v5.0', 'timeFrame': 'From patients participate in the clinical study to 90 days after the end of treatment', 'description': 'Adverse events as graded by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years', 'description': '1-year, 3-year, 5-year survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RWS', 'Advanced Liver Cancer', 'PD-1'], 'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer', 'detailedDescription': 'camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or more;\n* For both men and women;\n* Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.\n\nExclusion Criteria:\n\n* A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;\n* Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;\n* Pregnant or lactating women;\n* According to the judgment of the researcher, the patients should not be included in this study'}, 'identificationModule': {'nctId': 'NCT04487704', 'briefTitle': 'Camrelizumab Utilization on Patients With Advanced Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer', 'orgStudyIdInfo': {'id': 'XJYFY-KRLZ-HCC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Camrelizumab in the treatment of liver cancer', 'description': 'Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min', 'interventionNames': ['Other: camrelizumab']}], 'interventions': [{'name': 'camrelizumab', 'type': 'OTHER', 'description': 'camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG', 'armGroupLabels': ['Camrelizumab in the treatment of liver cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Lv, MD,PHD', 'role': 'CONTACT', 'email': 'luyi169@126.com', 'phone': '0086-13991200581'}, {'name': 'Xiaogang Zhang, Phd', 'role': 'CONTACT', 'email': 'zzsghr@qq.com', 'phone': '0086-13891803523'}, {'name': 'Yi Lv, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Xu-Feng Zhang, MD,phD', 'role': 'CONTACT', 'email': 'xfzhang125@126.com', 'phone': '86-029-13359260373'}, {'name': 'Rui Qu', 'role': 'CONTACT', 'email': '1289271841@qq.com', 'phone': '86-18681943306'}], 'overallOfficials': [{'name': 'Yi Lyu, MD,phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}