Combining Tislelizumab with targeted radiation for advanced head and neck cancer

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

This study is testing if combining a new immune therapy called Tislelizumab with targeted radiation can help people with advanced head and neck cancer have better surgery results and improve their overall health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone, Tislelizumab
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06673693 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of Tislelizumab, a PD-1 antibody, in combination with stereotactic body radiation therapy (SBRT) as a neoadjuvant treatment for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The study focuses on patients with resectable or marginally resectable tumors, aiming to improve surgical outcomes and overall patient prognosis. Participants will undergo a thorough evaluation to ensure they meet specific eligibility criteria, including performance status and age requirements.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed, resectable head and neck squamous cell carcinoma at clinical stage III to IVB.

Not a fit: Patients who have previously undergone head and neck surgery, chemotherapy, or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes and survival rates for patients with advanced head and neck cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and radiation, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chun-Yan Chen

Conditions Head and Neck Squamous Cell Carcinoma; HNSCC; SBRT; PD-1 antibody; Tislelizumab; Neoadjuvant Therapy