Can a One-Two punch of radiation and immunotherapy shrink head and neck tumors before surgery?
NCT ID NCT06673693
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This phase II trial is exploring whether combining stereotactic body radiation therapy (SBRT) with the immunotherapy drug tislelizumab, given before surgery, can help people with locally advanced head and neck squamous cell carcinoma. The study will enroll about 24 adults aged 18 to 70 with resectable tumors. The main goal is to see how many patients have a major pathological response—meaning few surviving tumor cells remain after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab (an immunotherapy drug) combined with stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this approach could shrink tumors before surgery, potentially improving outcomes for people with advanced head and neck cancer.
- What could go wrong
- This is a small, early-phase study, so results may not apply broadly. The combination may cause side effects or may not improve surgical outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can less radiation be enough after chemoimmunotherapy for head and neck cancer?
- Can a DNA vaccine boost immunotherapy against HPV-Linked head and neck cancer?
- Can a Three-Drug combo wipe out head and neck tumors before surgery?
- Can an immunotherapy combo shrink head and neck tumors before surgery?