Tislelizumab Combined with SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma

Phase 2

Not yet recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC); HNSCC
• Interventions: Drug: Tislelizumab

• Registration Number: NCT06673693
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study Start: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.
• Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer
• Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT
• Karnofsky Performance Status score ≥ 70
• Ages 18 to 70
• The primary organ functions meet the test requirements
• Patients participate voluntarily and sign informed consent forms

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Exclusion Criteria

• Patients previously treated with head and neck surgery were excluded from diagnostic biopsies of primary and regional lymph nodes
• 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
• Pregnant or lactating women
• Have had or co-had other malignancies
• The patient also has a serious, uncontrolled illness
• 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)
• 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
• History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease
• Active infections such as tuberculosis that require systemic treatment
• A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)
• 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)
• Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders
• The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results
• While participating in another therapeutic clinical study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT combined with PD-1	Tislelizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with MPR	From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months	MPR is defined as \< 10% of surviving tumor cells.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with pCR	From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months	pCR is defined as the absence of viable tumor cells in the postoperative specimen.
Number of Participants with downstaging in Clinical Pathological Staging as assessed by the AJCC 8th Edition Staging System	From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months	Utilization of the AJCC 8th Edition Staging System for Downstaging from Clinical to Pathological Staging
Median Progression-Free Survival	The time corresponding to a cumulative progression-free survival rate of 50%	The time corresponding to a cumulative progression-free survival rate of 50%
Median Overall Survival	The time corresponding to a cumulative overall survival rate of 50%	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.
Safety	From the commencement of neoadjuvant therapy until 30 days post-completion	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/possib...
Assessment of Quality of Life	Before treatment, prior to surgery, and within one week after all treatments are completed.	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\&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 in...

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China