Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-01-02 @ 12:59 AM
Study NCT ID:
NCT06143761
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'The time(years) from day 1 of study treatment until death from any cause.'}, {'measure': 'Disease-free survival （DFS）', 'timeFrame': '2 years', 'description': 'DFS(by months) is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoadjuvant chemoimmunotherapy, advanced oral squamous cell carcinoma, therapeutic response, predictive marker, prognosis'], 'conditions': ['Oral Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the effectiveness of neoadjuvant chemoimmunotherapy (NACI) regimens in treating advanced oral squamous cell carcinoma (OSCC) patients. We analyzed clinicopathologic features of advanced OSCC patients who received PD-1 inhibitors in combination with carboplatin and paclitaxel before surgical tumor resection between 2020 and 2022. The Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and pathologic response were used to evaluate the efficacy of the NACI treatment. Adverse events apparently related to NACI treatment were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Disease-free survival (DFS) and overall survival (OS) were calculated using the Kaplan-Meier survival curves and compared using the log rank test. Additionally, we calculated the area under curve (AUC) to compare the predictive value of PD-L1 expression with baseline serum lipid biomarkers for patient response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients underwent NACI before surgery\n* Patients accepted the surgery alone.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with advanced OSCC who received NACI before surgery\n\n* Confirmation of primary OSCC by two experienced pathologists;\n* Clinical stage III/ IVA (cT1-2/cN1-2/M0 or cT3-4a/cN0-2/M0) according to the 8th Edition of American Joint Committee on Cancer (AJCC) guideline;\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n* No prior anti-cancer therapy;\n* Locally resectable advanced tumor evaluated by a head and neck surgeon.\n\nAdvanced OSCC patients who only received surgery\n\n* A histopathologic diagnosis of primary OSCC;\n* A clinical stage of III/IVA (AJCC, 8th edition);\n* An ECOG performance status of 0 to 1.\n\nExclusion Criteria:\n\nPatients with advanced OSCC who received NACI before surgery\n\n* Patients with other pathological types, without NACI or Surgery;\n* Incomplete pre-treatment data;\n* Lost to follow up were excluded from the study.\n\nAdvanced OSCC patients who only received surgery\n\n* Patients who had received other therapies targeting the head and neck region before the surgery or those with evidence of recurrence or metastasis, as assessed by physical examination reports or imaging studies before surgery\n* Lost to follow up.'}, 'identificationModule': {'nctId': 'NCT06143761', 'acronym': 'HNC-SYSU-005', 'briefTitle': 'Response to Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'A Pilot Study of Neoadjuvant Chemoimmunotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'SYSKY-2023-184-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neoadjuvant chemoimmunotherapy+surgery', 'description': 'Patients who underwent neoadjuvant chemoimmunotherapy before surgery', 'interventionNames': ['Drug: PD-1 inhibitor+carboplatin+albumin-bound paclitaxel']}, {'label': 'surgery', 'description': 'Patients who accepted the surgery alone'}], 'interventions': [{'name': 'PD-1 inhibitor+carboplatin+albumin-bound paclitaxel', 'type': 'DRUG', 'description': 'A comparative evaluation of patient prognosis between those who received neoadjuvant chemoimmunotherapy-surgery treatment and those who underwent surgery alone.', 'armGroupLabels': ['neoadjuvant chemoimmunotherapy+surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jinsong Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}