Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-31 @ 12:32 AM
Study NCT ID:
NCT05532059
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2022-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}, {'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective remission rate (ORR)', 'timeFrame': '4 cycle treatment (each cycle is 21 days)', 'description': 'According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)'}], 'secondaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'From date of randomization until the date of first documented progression, assessed up to 60 months', 'description': 'The time between the date of randomization and the date of radiographic progression as defined by RECIST1.1'}, {'measure': 'Overall survival time (OS)', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 60 months', 'description': 'The time between the date of randomization and death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lenvatinib; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma'], 'conditions': ['Advanced Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. Therefore,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.\n* the world health organization (WHO)/ECOG physical state (PS) to 0 or 1.\n* at least 1 RECIST 1.1 standard target lesions.\n* not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.\n* adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L.\n\nExclusion Criteria:\n\n* Active or previously documented autoimmune disease or inflammatory disease.\n* Uncontrolled complications.\n* History of other primary malignancies.\n* Active infection.\n* Women who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05532059', 'briefTitle': 'Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma', 'orgStudyIdInfo': {'id': '20220901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GPLET', 'description': 'intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8; oral lenvatinib 8 mg/day (\\<60kg) or 12 mg/ d（≥60kg）from days 1 to 21; intravenous tislelizumab 200 mg on day 15', 'interventionNames': ['Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GP', 'description': 'intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8', 'interventionNames': ['Drug: gemcitabine and cisplatin']}], 'interventions': [{'name': 'Lenvatinib, tislelizumab, gemcitabine and cisplatin', 'type': 'DRUG', 'description': 'Lenvatinib, tislelizumab, gemcitabine and cisplatin', 'armGroupLabels': ['GPLET']}, {'name': 'gemcitabine and cisplatin', 'type': 'DRUG', 'description': 'gemcitabine and cisplatin', 'armGroupLabels': ['GP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'weilin wang, doctor', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+86 0571 87783820'}], 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}