Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 7:37 AM
Study NCT ID:
NCT06182657
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D000095384', 'term': 'Pathologic Complete Response'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'biopsy tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-12-25', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progress-free survival (PFS)', 'timeFrame': '3 years', 'description': 'PFS is defined as the time from treatment to date of first documentation of progression or death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '3 years', 'description': 'OS is defined as the time from treatment to death, regardless of disease recurrence.'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': '3 years', 'description': 'DMFS is defined as the time from diagnosis to the date of distant metastasis or when censored at the latest date.'}, {'measure': 'Pathological complete response (pCR) rate', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days).', 'description': 'pCR is defined as the absence of residual invasive.'}, {'measure': 'Infiltrating Immune cell density', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days).', 'description': 'CD3+ T cells, CD8+ T cells, CD20+ B cell and Tertiary lymphoid structure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma', 'Pathologic Complete Response', 'Tumor Microenvironment']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with biopsy proven stage III-IVA NPC (according to the 8th edition of Union for International Cancer Control stage classification).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to sign informed consent\n2. Age \\> 18 years at time of study entry\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (amend based on specific study)\n4. Histological confirmation of NPC (regardless if EBER positive or negative)\n5. Locally advanced NPC, UICC stage III-IVa\n6. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n2. Distant metastases\n3. Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced NPC.\n4. History of another primary malignancy\n5. Female patients who are pregnant\n6. Known allergy or hypersensitivity to any drugs\n7. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.'}, 'identificationModule': {'nctId': 'NCT06182657', 'briefTitle': 'The Prognostic Value of the Degree of Pathological Response of Induction Chemotherapy for NPC', 'organization': {'class': 'OTHER', 'fullName': 'Jiangxi Provincial Cancer Hospital'}, 'officialTitle': 'The Prognostic Value of the Degree of Pathological Response at One Cycle of Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinon-a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'NPC-pCR'}}, 'contactsLocationsModule': {'locations': [{'zip': '330029', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianzhu Lu', 'role': 'CONTACT', 'email': 'lutianzhu2008@163.com', 'phone': '8615270186250'}, {'name': 'Xiaochang Gong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jingao Li', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Jingao Li, PhD', 'role': 'CONTACT', 'email': 'lijingao@hotmail.com', 'phone': '8613970866296'}, {'name': 'Tianzhu Lu, PhD', 'role': 'CONTACT', 'email': 'lutianzhu2008@163.com'}], 'overallOfficials': [{'name': 'Jingao Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangxi Provincial Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangxi Provincial Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}