Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-30 @ 4:04 AM
Study NCT ID:
NCT04544969
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The coincidence rate between drug sensitivity test in CTCs and objective response rate', 'timeFrame': '6 months', 'description': 'Comparison the coincidence rate between drug sensitivity test in CTCs and objective response rate of corresponding chemotherapy regime'}], 'secondaryOutcomes': [{'measure': 'The changes of CTCs countings', 'timeFrame': 'Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy'}, {'measure': 'Objective response rate', 'timeFrame': 'study period of 19 Months', 'description': 'To be determined by measurement of target lesions according to RECIST criteria'}, {'measure': 'Progression free survival', 'timeFrame': 'baseline', 'description': 'Defined as the time in months from first course of treatment until PD is observed or death occurs due to any cause.'}, {'measure': 'Cutoff value of CTC counts', 'timeFrame': 'Objective response at 6 months', 'description': 'to identify patients with early relapse (\\<6 months) after liver resection as determined by the AUC under the ROC curve'}, {'measure': 'Predictive value of the changes of CTCs countings', 'timeFrame': 'Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circulating Tumor Cell', 'Nasopharyngeal Carcinoma', 'Distant Metastases.Clinical', 'Effects of Chemotherapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sysucc.org.cn', 'label': 'Home Page of Cancer Center, Sun Yat-sen University'}]}, 'descriptionModule': {'briefSummary': "The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NPC patients with distant metastasis after 3 months of primary radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment\n* At least having one measurable metastatic lesion\n* All genders，range from 18～70 years old\n* ECOG score 0 \\~ 1\n* Expected survival time ≥ 3 months\n* White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L\n* Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \\< 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) \\< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min\n* Inform consent form\n\nExclusion Criteria:\n\n* Have or are suffering from other malignant tumors;\n* Participating in other clinical trials;\n* Drug or alcohol addition;\n* Do not have full capacity for civil acts;\n* Mental disorder;\n* Pregnancy or lactation;\n* Severe complication, eg, uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT04544969', 'briefTitle': 'Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients', 'orgStudyIdInfo': {'id': 'B2019-128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy', 'description': 'Patients treated with palliative chemotherapy', 'interventionNames': ['Drug: cisplatin-based chemotherapy']}], 'interventions': [{'name': 'cisplatin-based chemotherapy', 'type': 'DRUG', 'otherNames': ['docetaxel and cisplatin', 'fluorouracil and cisplatin', 'docetaxel, fluorouracil and cisplatin', 'gemcitabine and cisplatin'], 'description': "GP: cisplatin 80 mg/m2 intravenous infusion on day1, gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8, both drugs are given every 3 weeks, recommended 6 cycles.\n\nTP: cisplatin 75 mg/m2 intravenous infusion in day1, docetaxel 75 mg/m2 intravenous infusion in day 1, both drugs are given every 3 weeks, recommended 6 cycles.\n\nPF: cisplatin 100 mg/m2 intravenous infusion in day1, fluorouracil 4000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles.\n\nTPF: cisplatin 60 mg/m2 intravenous infusion in day1, docetaxel 60 mg/m2 intravenous infusion in day 1, fluorouracil 3000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles.\n\nChoice of chemotherapy regimen is decided by patient's doctor in charge.", 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chong Zhao', 'role': 'CONTACT', 'email': 'zhaochong@sysucc.org.cn', 'phone': '02087342638'}], 'facility': 'Cancer Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jingjing Miao, M.D', 'role': 'CONTACT', 'email': 'miaojingjing90@163.com', 'phone': '86-13631355201'}], 'overallOfficials': [{'name': 'Chong Zhao, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Zhao Chong', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}