Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04692051
Status:
UNKNOWN
Last Update Posted:
2020-12-31
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-29', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to 3 years', 'description': 'PFS is defined as time from the start of treatment to progression of disease or death.'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 3 years', 'description': 'The rate of participants that achieve either a complete response (CR) or a partial response (PR).'}, {'measure': 'OS', 'timeFrame': 'up to 3 years', 'description': 'Overall survival is defined as time from the start of treatment until death due to any reason.'}, {'measure': 'TTP', 'timeFrame': 'up to 3 years', 'description': 'Time to progress is defined as time from randomized grouping to objective progression of tumors.'}, {'measure': 'AEs', 'timeFrame': 'up to 3 years', 'description': 'Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nab-paclitaxel + Cisplatin'], 'conditions': ['Biliary Tract Cancer']}, 'referencesModule': {'references': [{'pmid': '40819029', 'type': 'DERIVED', 'citation': 'Yang X, Dai YH, Peng H, Zhang MS, Fu Q, Liu SF, Sun L, Zou YM, Xu HS, Qiu P, Qiu H, Huang Q, Cheng HH, Zhuang L. Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial. BMC Cancer. 2025 Aug 16;25(1):1321. doi: 10.1186/s12885-025-14581-3.'}]}, 'descriptionModule': {'briefSummary': 'It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 70 years;\n2. Diagnosis of unresectable or recurrent or metastatic biliary tract cancer (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts);\n3. Adequate bone marrow, liver and kidney function: absdute neutrophil count (ANC) ≥ 1.5 x 10\\^9/L, platelet count (PLT) ≥75 x 10\\^9/L, hemoglobin (HB) ≥ 75 g/L, White blood cell(WBC) ≥ 3.0 x 10\\^9/L, no bleeding symptoms or bleeding tendency; Total bilirubin (TBIL) ≤ 3 x upper limit of normal range (ULN), alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤ 5 x upper limit of normal range (ULN); creatinine(Cr) ≤ 1.5 x upper limit of normal range(ULN) or creatinine clearance rate（CCR）≥ 45ml/min;\n4. At least one measurable lesion;\n5. Karnofsky Performance Status(KPS) ≥ 70;\n6. Estimated life expectancy of at least 3 months;\n7. Resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1, with the exception of alopecia;\n8. Be able to understand and willingness to sign IRB-approved informed consent; (If the patient cannot sign the informed consent due to consciousness disorder, upper limbs paralysis or inability to write, the legal representative shall sign the informed consent on behalf of the patient).\n\nExclusion Criteria:\n\n1. Ongoing uncontrolled infections, or have received systemic antibiotic therapy within 72 hours prior to registration;\n2. Myeloproliferative disorder or any other hematopoietic function disorder;\n3. Have an untreated second malignancy or brain metastasis;\n4. Allergic to the chemotherapy drugs of this protocol;\n5. Unable to cooperate due to neurologic diseases or psychiatric illness;\n6. Pregnant or lactating female patients; Women of child-bearing age who refuse to accept contraceptive measures;\n7. Have other significant medical illness, for example,active tuberculosis, active pneumonia, uncorrected electrolyte disturbance, uncontrolled tumor associated pain, uncontrolled hydrothorax or seroperitoneum and so on;\n8. Patients need to receive other antitumor therapy at the same time;\n9. Have received any other experimental treatment or participated in another interventional clinical trial within 30 days prior to registration;\n10. Any other situation that the researcher considered patients are unsuitable for the trial.'}, 'identificationModule': {'nctId': 'NCT04692051', 'briefTitle': 'A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer', 'orgStudyIdInfo': {'id': 'CSPC-KAL-BTC-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-paclitaxel + Cisplatin', 'description': 'Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin', 'interventionNames': ['Drug: Nab-paclitaxel + Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine + Cisplatin', 'description': 'Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin', 'interventionNames': ['Drug: Gemcitabine + Cisplatin']}], 'interventions': [{'name': 'Nab-paclitaxel + Cisplatin', 'type': 'DRUG', 'description': 'Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.', 'armGroupLabels': ['Nab-paclitaxel + Cisplatin']}, {'name': 'Gemcitabine + Cisplatin', 'type': 'DRUG', 'description': 'Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.', 'armGroupLabels': ['Gemcitabine + Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Zhuang, professor', 'role': 'CONTACT', 'email': 'mrzhuangliang@126.com', 'phone': '+8613006325115'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Liang Zhuang, professor', 'role': 'CONTACT', 'email': 'mrzhuangliang@126.com', 'phone': '+8613006325115'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of the cancer center', 'investigatorFullName': 'Xianglin Yuan', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}