Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:06 AM
Study NCT ID:
NCT05816694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate (ORR)', 'timeFrame': 'assessed up to 1 year', 'description': 'the proportion of patients with complete response and partial response , using RECIST v 1.1'}], 'secondaryOutcomes': [{'measure': '3-year disease free survival (3yr-DFS)', 'timeFrame': 'assessed up to 3 year', 'description': 'the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients'}, {'measure': 'overall survival rate (OS)', 'timeFrame': 'assessed up to 3 year', 'description': 'from date of enrolment to date of death of any reason'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'assessed up to 1 year'}, {'measure': 'Surgical conversion success rate', 'timeFrame': 'assessed up to 1 year', 'description': 'Following chemotherapy to evaluate proportion of patients underwent timely operation'}, {'measure': 'Pathologic Complete Response（pCR）', 'timeFrame': 'assessed up to 1 year', 'description': 'the proportion of patients with complete response , using RECIST v 1.1'}, {'measure': 'Main pathological Response', 'timeFrame': 'assessed up to 1 year', 'description': 'the proportion of patients with complete response and partial response , using RECIST v 1.1'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation', 'CEP (cisplatin, epirubicin,cyclophosphamide)', 'thymoma'], 'conditions': ['Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma']}, 'descriptionModule': {'briefSummary': 'This study for a single-center prospective phase II randomized controlled train to assess the efficacy and safety of Induction therapy on thymoma .Methods patients with thymoma (stage Ⅲ and stage Ⅳa) were treated with 2 cycles of (NAB)-paclitaxel plus Cisolation (Paclitaxel For Injection(Aalbumin Bound）125 mg/m2 Day 1 、Day8 ,Cisplatin 75 mg/m2 Day 1of each 3-week cycle）or CEP(cisplatin 50 mg/m2 Day 1, epirubicin 75 mg/m2 Day 1,cyclophosphamide 500 mg/m2 Day 1 of each 3-week cycle). Following chemotherapy to evaluate the patient for operation. Patients without undergo surgery will be continued to receive 2 cycles of Primary chemotherap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years；\n* Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma;\n* PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion；\n* Life expectancy \\>12months；\n* ECOG PS 0-1；\n\n --Patients with thymoma metastasis；\n* No found the other malignant tumors (expect has been controlled Carcinoma in situ of the cervix and Basal Cell Carcinoma）；\n* Informed consent was signed before the study began；\n* Normal Bone marrow hematopoiesis and renal function，Blood routine: absolute neutrophil count≥1,500/uL，Hb\\>8.0g/dL，PLT\\>80×10\\*9/L，AST≤ 1.5 times the upper limit of normal，TBIL ≤1.5 times the upper limit of normal，calculated creatinine clearance ≤110µmol/L，blood urea nitrogen≤7.1mmol/L；\n* Cardiac function: LVEF≥55%；\n* Patients who have not active bleeding or coagulopathy before enrollment；\n\nExclusion Criteria:\n\n* -Patients who have been found thymoma metastasis；\n* Patients with uncontrolled lung disease, Serious infection,active peptic ulcers, coagulation diaorders, Uncontrolled severe diabetes, connective tissue diseases or Bone marrow suppression and Induction therapy for intolerance；\n* Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 )；\n* Significant organ dysfunction: such as respiratory failure, NYHA classification Class III or IV, chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure（SBP\\> 180 mmHg or DBP\\> 100mmHg）；\n* Pregnant and lactating women；\n* patients without undergo preoperative puncture biopsy or induction therapy；\n* Patients with active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response；\n* Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；\n* Known HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded；\n* Patients with uncontrollable Stable myasthenia gravis or uncontrollable Serious autoimmune disease such as fulminant DIC；\n* Patients who are known to be allergic or intolerant to chemotherapy drugs；\n* severe-trauma；\n* Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；'}, 'identificationModule': {'nctId': 'NCT05816694', 'briefTitle': 'The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.', 'orgStudyIdInfo': {'id': 'B2021-584R2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CEP', 'description': 'Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.', 'interventionNames': ['Drug: Cisplatin plus Epirubicin plus Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'NAB-Paclitaxel', 'description': 'NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.', 'interventionNames': ['Drug: NAB-Paclitaxel plus Cisplatin']}], 'interventions': [{'name': 'NAB-Paclitaxel plus Cisplatin', 'type': 'DRUG', 'description': 'NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.', 'armGroupLabels': ['NAB-Paclitaxel']}, {'name': 'Cisplatin plus Epirubicin plus Cyclophosphamide', 'type': 'DRUG', 'description': 'Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.', 'armGroupLabels': ['CEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Yian Zhang', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Bei Xu, Ph.D', 'role': 'CONTACT', 'email': 'xu.bei2@zs-hospital.sh.cn', 'phone': '13817687547'}, {'name': 'Yue Fan, Ph.D', 'role': 'CONTACT', 'email': 'fan.yue@zs-hospital.sh.cn', 'phone': '13901874150'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peng Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Peng Liu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}