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Clinical Trials/NCT06673693
NCT06673693Active, not recruitingPhase 2

Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study

Sun Yat-sen University1 site in 1 country24 target enrollmentStarted: June 25, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Number of Participants with MPR
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Arms & Interventions

SBRT combined with PD-1

Experimental

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.

Intervention: Tislelizumab (Drug)

Outcomes

Primary Outcomes

Number of Participants with MPR

Time Frame: 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 Outcomes

  • Number of Participants with pCR(From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months)
  • 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)
  • Median Progression-Free Survival(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%)
  • Safety(From the commencement of neoadjuvant therapy until 30 days post-completion)
  • Assessment of Quality of Life(Before treatment, prior to surgery, and within one week after all treatments are completed.)

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chen Chunyan

Prof.

Sun Yat-sen University

Study Sites (1)

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