Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06235918
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (PCR)', 'timeFrame': 'From neoadjuvant therapy to surgical resection, up to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Major Pathological Response (MPR)', 'timeFrame': 'From neoadjuvant therapy to surgical resection, up to 6 weeks', 'description': 'In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.'}, {'measure': '3-year Disease-free survival (DFS) rate', 'timeFrame': '3-years after surgery', 'description': 'Time from randomization to disease recurrence or death of any cause'}, {'measure': '3-year overall survival（OS）rate', 'timeFrame': '3-years after surgery', 'description': 'The proportion of all study cases in which no death from any cause occurred within 3 years after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Squamous Cell Carcinomas', 'Resectable Head and Neck Squamous-cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who voluntarily participate in the project and sign the informed consent.\n2. Be 18 years of age on day of signing informed consent.\n3. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1.\n4. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.\n5. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.\n6. Demonstrate adequate organ function.\n\nExclusion Criteria:\n\n1. The patient has abnormal blood indicators, abnormal liver and kidney function.\n2. The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.\n3. The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.\n4. The entire clinical research process cannot be completed due to personal, social and economic reasons.\n5. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .'}, 'identificationModule': {'nctId': 'NCT06235918', 'briefTitle': 'Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial', 'orgStudyIdInfo': {'id': 'TJ-IRB20220529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant therapy of tislelizumab with chemotherapy', 'description': 'Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Nab-paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317'], 'description': 'Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles', 'armGroupLabels': ['Neoadjuvant therapy of tislelizumab with chemotherapy']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': '260mg/m\\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles', 'armGroupLabels': ['Neoadjuvant therapy of tislelizumab with chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles', 'armGroupLabels': ['Neoadjuvant therapy of tislelizumab with chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Lu, professor', 'role': 'CONTACT', 'email': 'luxiangent@hotmail.com', 'phone': '027-83662691'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xiang Lu, professor', 'role': 'CONTACT', 'email': 'luxiangent@hotmail.com', 'phone': '027-83662691'}], 'overallOfficials': [{'name': 'Guangyuan Hu, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiang Lu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiang Lu', 'investigatorAffiliation': 'Tongji Hospital'}}}}