Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 7:16 PM
Study NCT ID:
NCT06673693
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With SBRT for the Treatment of 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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with MPR', 'timeFrame': 'From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months', 'description': 'MPR is defined as \\< 10% of surviving tumor cells.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with pCR', 'timeFrame': 'From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months', 'description': 'pCR is defined as the absence of viable tumor cells in the postoperative specimen.'}, {'measure': 'Number of Participants with downstaging in Clinical Pathological Staging as assessed by the AJCC 8th Edition Staging System', 'timeFrame': 'From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months', 'description': 'Utilization of the AJCC 8th Edition Staging System for Downstaging from Clinical to Pathological Staging'}, {'measure': 'Median Progression-Free Survival', 'timeFrame': 'The time corresponding to a cumulative progression-free survival rate of 50%', 'description': 'The time corresponding to a cumulative progression-free survival rate of 50%'}, {'measure': 'Median Overall Survival', 'timeFrame': 'The time corresponding to a cumulative overall survival rate of 50%', 'description': 'The time corresponding to a cumulative overall survival rate of 50%. Survival rate is defined as the time from the initiation of the first treatment to death from any cause.'}, {'measure': 'Safety', 'timeFrame': 'From the commencement of neoadjuvant therapy until 30 days post-completion', 'description': 'Assessment of treatment-related adverse events using the Common Terminology Criteria for Adverse Events (CTCAE 5.0) is conducted from the initiation of neoadjuvant therapy through 30 days post-completion of all treatments. Adverse reactions are defined as adverse events related to the investigational drug with a relationship deemed "definitely related/possibly related/unable to determine.'}, {'measure': 'Assessment of Quality of Life', 'timeFrame': 'Before treatment, prior to surgery, and within one week after all treatments are completed.', 'description': 'The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H\\&amp;N35) version 1.0, which represent functions, symptoms, or health conditions. The European Organization for Cancer Research and Treatment QLQ-C30 （EORTC QLQ-C30）: a quality of life instrument for use in international clinical trials in oncology. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SBRT', 'PD-1 antibody', 'Tislelizumab', 'Neoadjuvant Therapy'], 'conditions': ['Head and Neck Squamous Cell Carcinoma (HNSCC)', 'HNSCC']}, 'descriptionModule': {'briefSummary': 'Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.\n* Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer\n* Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT\n* Karnofsky Performance Status score ≥ 70\n* Ages 18 to 70\n* The primary organ functions meet the test requirements\n* Patients participate voluntarily and sign informed consent forms\n\nExclusion Criteria:\n\n* Patients previously treated with head and neck surgery were excluded from diagnostic biopsies of primary and regional lymph nodes\n* Previous chemotherapy for any reason, or radiotherapy in the head and neck area, or molecular targeted drug therapy; Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs acting on another irritating or co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) treatment, or cell biotherapy\n* Pregnant or lactating women\n* Have had or co-had other malignancies\n* The patient also has a serious, uncontrolled illness\n* Heart, brain, lung and other important organ function abnormal. Patients with hypertension (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg) who cannot be reduced to the normal range by antihypertensive drugs have grade I or above myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiac insufficiency; Abnormal coagulation function (INR \\>1.5 or prothrombin time (PT) \\> ULN+4 seconds or APTT \\>1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantification \\>1.0g)\n* Glucocorticoid therapy for 30 days prior to initial administration (prednisone equivalent dose \\> 10mg daily); Have an active autoimmune disease that has required systemic treatment (i.e., disease-modulating drugs, corticosteroids, or immunosuppressive drugs) in the last 2 years\n* History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease\n* Active infections such as tuberculosis that require systemic treatment\n* A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)\n* Untreated active hepatitis B; Note: Hepatitis B subjects who met the following criteria were also eligible for inclusion: HBV viral load must be \\<1000 copies /ml (200 IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout study chemotherapeutic therapy. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)\n* Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders\n* The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results\n* While participating in another therapeutic clinical study'}, 'identificationModule': {'nctId': 'NCT06673693', 'acronym': 'NEOSTART', 'briefTitle': 'Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study', 'orgStudyIdInfo': {'id': '2024-FXY-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT combined with PD-1', 'description': 'Week 1: SBRT radiation therapy administered as 24Gy/3f, on days 1, 3, and 5. Weeks 2-5: Tislelizumab 200mg intravenous drip every 3 weeks, for a total of two cycles.', 'interventionNames': ['Drug: Tislelizumab']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'SBRT', 'armGroupLabels': ['SBRT combined with PD-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun-Yan Chen, MD', 'role': 'CONTACT', 'email': 'chenchuny@sysucc.org.cn', 'phone': '13826423812', 'phoneExt': '86'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun-Yan Chen, Prof.', 'role': 'CONTACT', 'email': 'chenchuny@sysucc.org.cn', 'phone': '020-87341779'}, {'name': 'Ya-Ni Zhang, Dr.', 'role': 'CONTACT', 'email': 'zhangyn1@sysucc.org.cn', 'phone': '02087342925'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chun-Yan Chen', 'role': 'CONTACT', 'email': 'chenchuny@sysucc.org.cn', 'phone': '13826423812', 'phoneExt': '86'}, {'name': 'Ya-Ni Zhang', 'role': 'CONTACT', 'email': 'zhangyn1@sysucc.org.cn', 'phone': '15914271501', 'phoneExt': '86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Chen Chunyan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}