Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2NEOSTARTNCT06673693
Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HNSCC, run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC), HNSCC
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study
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).
- Being tested
- Tislelizumab
- Keywords
- SBRT, PD-1 antibody, Tislelizumab, Neoadjuvant Therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called Radiotherapy
SBRT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with MPR
MPR is defined as < 10% of surviving tumor cells.
Measured: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
Secondary outcomes (6)
Number of Participants with pCR
pCR is defined as the absence of viable tumor cells in the postoperative specimen.
Measured: 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
Utilization of the AJCC 8th Edition Staging System for Downstaging from Clinical to Pathological Staging
Measured: 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%
Measured: 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%. Survival rate is defined as the time from the initiation of the first treatment to death from any cause.
Measured: The time corresponding to a cumulative overall survival rate of 50%
Safety
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.
Measured: From the commencement of neoadjuvant therapy until 30 days post-completion
Assessment of Quality of Life
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.
Measured: Before treatment, prior to surgery, and within one week after all treatments are completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start25 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Chunyan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673693
- Sponsor's protocol ID
- 2024-FXY-179
- Acronym
- NEOSTART
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06673693
- Acronym / sponsor ID
- NEOSTART / 2024-FXY-179
- Keywords
- SBRT, PD-1 antibody, Tislelizumab, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT combined with PD-1 | Experimental | Drug: TislelizumabWeek 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: RadiotherapySBRT | Drug | SBRT combined with PD-1 |
Primary outcome
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.
6 secondary outcomes
Number of Participants with pCR
Time frame: 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
Time frame: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
Median Progression-Free Survival
Time frame: The time corresponding to a cumulative progression-free survival rate of 50%
Median Overall Survival
Time frame: The time corresponding to a cumulative overall survival rate of 50%
Safety
Time frame: From the commencement of neoadjuvant therapy until 30 days post-completion
Assessment of Quality of Life
Time frame: Before treatment, prior to surgery, and within one week after all treatments are completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HNSCC, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with MPR (time frame: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.