Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT04803851
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2021-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-18', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease control rate (DCR) based on RECIST v. 1 1', 'timeFrame': '6 weeks', 'description': 'Disease control rate (DCR) based on RECIST v. 1 1 by investigators'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) based on RECIST V. 1.1', 'timeFrame': '6 weeks', 'description': 'Objective response rate (ORR) based on RECIST V. 1.1 by investigators'}, {'measure': 'Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression', 'timeFrame': '6 weeks', 'description': 'Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment'}, {'measure': 'Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause', 'timeFrame': '6 weeks', 'description': 'Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '6 weeks', 'description': 'adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anlotinib', 'Anti-PD-1 Antibody', 'Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* locally advanced or metastatic pancreatic cancer (PC),\n* histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,\n* failed to second-line chemotherapy for PC,\n* 18-75 years of age,\n* an Eastern Cooperative Oncology Group performance status score of 0 to 1,\n* adequate organ functions\n\nExclusion Criteria:\n\n* had received PD 1 /CTLA 4 antibody treatment\n* had received anti-VEGFR inhibitors or antibodies'}, 'identificationModule': {'nctId': 'NCT04803851', 'briefTitle': 'Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study', 'orgStudyIdInfo': {'id': 'JS2791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Anlotinib plus AK105', 'interventionNames': ['Drug: Anlotinib plus AK105']}], 'interventions': [{'name': 'Anlotinib plus AK105', 'type': 'DRUG', 'description': 'Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiang5123@126.com', 'phone': '011-86-10-69151279'}], 'facility': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'XIANG WANG, Master', 'role': 'CONTACT', 'email': 'wangxiang5123@126.com', 'phone': '86-1069158773'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}