Resectable Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT07379424
A Single-arm, Phase II, Multi-center Clinical Trial of Sintilimab During the Perioperative Period in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Adjuvant therapy: sintilimab combined with radiotherapy in people with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma, run by chen chao Professor at 1 site in China.
Trial summary
This study is a single-arm, multi-center Phase II clinical trial. As depicted in the following study design diagram, its objective is to observe and assess the efficacy and safety of sintilimab during the perioperative period in patients with resectable locally advanced head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Adjuvant therapy: sintilimab combined with radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 25 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Written informed consent was obtained before any trial-related procedures were performed; 2. Male or female ≥18 years old; 3. Patients with locally advanced squamous cell carcinoma of the head and neck, including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers (except nasopharyngeal and paranasal sinus cancers), confirmed histologically or cytologically by investigator assessment as resectable, including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers; 4. Enrollment stage: stage III-IVA (AJCC 8th); 5. Operable and willing to accept radical surgery after evaluation by multidisciplinary team; 6. The patient had not received any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
- 7. At least one radiographic measurable lesion according to response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 8. ECOG PS score of 0-1; 9. Expected survival time \> 3 months; 10. Adequate organ function, subject must meet the following laboratory indicators:
- absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days.
- platelet count ≥100×109/L without blood transfusion in the past 14 days.
- hemoglobin \> in the absence of blood transfusion or erythropoietin use in the last 14 days; 9g/dL;
- Total bilirubin ≤1.5× upper limit of normal value (ULN);
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- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN
- serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
- good coagulation function, defined as INR or PT ≤1.5 times ULN;
- Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range.
- Myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed); 11. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy.
- 12. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy drug).
Who cannot join
- Nasopharyngeal or paranasal sinus cancer;
- Distant metastasis confirmed by clinical or imaging examination;
- Malignant diseases other than head and neck squamous cell carcinoma (excluding radical basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection carcinoma in situ) diagnosed within 3 years before the first dose;
- Currently participating in an interventional clinical study treatment, or receiving another study drug or using a study device within 4 weeks before the first dose;
- Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
- Received anti-tumor Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with systemic treatment within 2 weeks before the first dose;
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- Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy;
- Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose; Note: Physiologic doses of glucocorticoids (prednisone ≤10mg/ day or equivalent) were allowed.
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known to be allergic to sintilimab or excipients;
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive);
- Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center);
- Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion:
- HBV viral load \< before the first dose; 1000 copies /ml (200IU/ml), subjects should receive anti-HBV therapy throughout the study chemotherapy to avoid viral reactivation
- Subjects with anti-HBc (+), HBsAg (-), anti-hbs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required
- Active HCV-infected subjects (HCV-antibody positive with an HCV-RNA level above the lower limit of detection);
- Have received a live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed.
- Pregnant or lactating women;
- The presence of any serious or uncontrolled systemic illness, such as:
- significant rhythm, conduction or morphological abnormalities on resting ECG that are symptomatic and difficult to control, such as complete left bundle branch block, ≥ Ⅱ degree heart block, ventricular arrhythmia or atrial fibrillation;
- unstable angina, congestive heart failure, New York Heart Association (NYHA) class ≥2 chronic heart failure;
- any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, etc. within 6 months before enrollment;
- poor blood pressure control (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg);
- a history of noninfectious pneumonia requiring glucocorticoid therapy within 1 year before the first dose or current clinically active interstitial lung disease;
- active pulmonary tuberculosis;
- presence of active or uncontrolled infection requiring systemic therapy;
- clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
- liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L);
- urine routine showed urinary protein ≥++ and confirmed 24-hour urinary protein quantitation > 1.0g;
- patients with mental disorders who are unable to cooperate with treatment;
- Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions deemed by the investigator to be inappropriate for enrollment that may interfere with the results of the trial or preclude full participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ting Jin, M.D, 15968837040, jinting22222@163.com
About this study
This study is a single-arm, multi-center Phase II clinical trial. As depicted in the following study design diagram, its objective is to observe and assess the efficacy and safety of sintilimab during the perioperative period in patients with resectable locally advanced head and neck squamous cell carcinoma.
Read the detailed description
The study aims to recruit patients with head and neck squamous cell carcinoma that has been histologically or cytologically confirmed. The patients should be newly diagnosed, resectable, locally advanced, and have not received any treatment for malignant tumors, as evaluated by the researchers. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, the patients will first receive sintilimab in combination with standard chemotherapy (the specific drugs will be determined by the researchers). Sintilimab will be administered at a dosage of 200 mg, once every three weeks (Q3W).It is administered via intravenous infusion on the first day of each cycle. Efficacy evaluation is conducted after two cycles of treatment. For patients who show a response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) during the efficacy evaluation, surgical resection will be performed. Following surgical resection, sintilimab combined with radiotherapy will be initiated. Sintilimab is administered every three weeks for a total of 15 cycles. Treatment will continue until disease progression, recurrence, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances specified in the protocol that necessitate treatment discontinuation, whichever occurs first. The study employs RECIST v1.1 for imaging assessment. The baseline assessment will be conducted within 28 days prior to enrollment. Following 2 cycles of neoadjuvant therapy, a tumor imaging assessment will be performed once. After surgical resection, tumor imaging assessments will be conducted every 3 months (±7 days). If the imaging examination prior to signing the Informed Consent Form (ICF) is within 28 days before the initiation of treatment, it can be utilized as a screening period examination. For subjects who discontinue treatment for reasons other than disease recurrence or death, imaging assessments will also be carried out every 3 months during the first two years after treatment completion, and then every 6 months starting from the third year until a progression or death event occurs. The study will also delve into predictive efficacy biomarkers. For subjects who have signed the informed consent for biomarker sample collection, biomarker blood samples and tumor samples will be collected during the baseline period and throughout the trial. This includes possible tumor biopsies during the baseline period.
- Being tested
- Adjuvant therapy: sintilimab combined with radiotherapy
- Keywords
- HNSCC, Resectable local advanced HNSCC
- 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.
Adjuvant therapy: sintilimab combined with radiotherapyCombination product
The efficacy was assessed following 2 cycles of neoadjuvant therapy. Patients with efficacy evaluated as CR/PR/SD/PD underwent surgical resection. After surgical resection, sintilimab combined with radiotherapy was initiated as adjuvant therapy, and sintilimab was administered at a dosing interval of Q3W for 15 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + PD-1 inhibitor | Experimental | Neoadjuvant therapy: PD-1 inhibitor combined with chemotherapy
Sintilimab:
* Specification: 100 mg/10 ml
* Administration method: 200 mg IV infusion, Q3W, 2 cycles; Standard chemotherapy: paclitaxel (albumin-bound) 260mg/m2 d1+ cisplatin 80mg/m2 d1 or paclitaxel (albumin-bound) 260mg/m2 d1+ nedaplatin 80mg/m2 d1. Receives: Combination Product: Adjuvant therapy: sintilimab combined with radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year DFS rate
Investigator-assessed relapse-free survival at 1 year according to RECIST v1.1
Measured: 1 year
Secondary outcomes (6)
ORR
The objective response rate was assessed according to RECIST 1.1 criteria
Measured: Six weeks after enrollment
DCR
Disease control rate based on RECIST 1.1 criteria
Measured: Six weeks after enrollment
pCR
Refers to the proportion of patients with no residual tumor in the primary tumor and lymph nodes resected
Measured: Six weeks after enrollment
MPR
Refers to the proportion of patients with ≤10% viable tumor cells in the postoperative resection specimen
Measured: Six weeks after enrollment
OS
Overall survival
Measured: Occurrence or end of follow-up（3 years after enrollment), which comes first
AE
The severity of adverse events was graded during the study and during follow-up according to the NCI CTCAE, version 5.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- chen chao Professor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, chen chao Professor, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379424
- Sponsor's protocol ID
- IRB-2025-600(IIT)
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II, Multi-center Clinical Trial of Sintilimab During the Perioperative Period in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07379424
- Acronym / sponsor ID
- IRB-2025-600(IIT)
- Keywords
- HNSCC, Resectable local advanced HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- chen chao ProfessorUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 30 Jan 2026 (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.
This study is a single-arm, multi-center Phase II clinical trial. As depicted in the following study design diagram, its objective is to observe and assess the efficacy and safety of sintilimab during the perioperative period in patients with resectable locally advanced head and neck squamous cell carcinoma.
Detailed description
The study aims to recruit patients with head and neck squamous cell carcinoma that has been histologically or cytologically confirmed. The patients should be newly diagnosed, resectable, locally advanced, and have not received any treatment for malignant tumors, as evaluated by the researchers. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, the patients will first receive sintilimab in combination with standard chemotherapy (the specific drugs will be determined by the researchers). Sintilimab will be administered at a dosage of 200 mg, once every three weeks (Q3W).It is administered via intravenous infusion on the first day of each cycle. Efficacy evaluation is conducted after two cycles of treatment. For patients who show a response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) during the efficacy evaluation, surgical resection will be performed. Following surgical resection, sintilimab combined with radiotherapy will be initiated. Sintilimab is administered every three weeks for a total of 15 cycles. Treatment will continue until disease progression, recurrence, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances specified in the protocol that necessitate treatment discontinuation, whichever occurs first. The study employs RECIST v1.1 for imaging assessment. The baseline assessment will be conducted within 28 days prior to enrollment. Following 2 cycles of neoadjuvant therapy, a tumor imaging assessment will be performed once. After surgical resection, tumor imaging assessments will be conducted every 3 months (±7 days). If the imaging examination prior to signing the Informed Consent Form (ICF) is within 28 days before the initiation of treatment, it can be utilized as a screening period examination. For subjects who discontinue treatment for reasons other than disease recurrence or death, imaging assessments will also be carried out every 3 months during the first two years after treatment completion, and then every 6 months starting from the third year until a progression or death event occurs. The study will also delve into predictive efficacy biomarkers. For subjects who have signed the informed consent for biomarker sample collection, biomarker blood samples and tumor samples will be collected during the baseline period and throughout the trial. This includes possible tumor biopsies during the baseline period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + PD-1 inhibitor | Experimental | Combination Product: Adjuvant therapy: sintilimab combined with radiotherapyNeoadjuvant therapy: PD-1 inhibitor combined with chemotherapy Sintilimab: * Specification: 100 mg/10 ml * Administration method: 200 mg IV infusion, Q3W, 2 cycles; Standard chemotherapy: paclitaxel (albumin-bound) 260mg/m2 d1+ cisplatin 80mg/m2 d1 or paclitaxel (albumin-bound) 260mg/m2 d1+ nedaplatin 80mg/m2 d1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Written informed consent was obtained before any trial-related procedures were performed; 2. Male or female ≥18 years old; 3. Patients with locally advanced squamous cell carcinoma of the head and neck, including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers (except nasopharyngeal and paranasal sinus cancers), confirmed histologically or cytologically by investigator assessment as resectable, including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers; 4. Enrollment stage: stage III-IVA (AJCC 8th); 5. Operable and willing to accept radical surgery after evaluation by multidisciplinary team; 6. The patient had not received any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
- 7. At least one radiographic measurable lesion according to response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 8. ECOG PS score of 0-1; 9. Expected survival time \> 3 months; 10. Adequate organ function, subject must meet the following laboratory indicators:
- absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days.
- platelet count ≥100×109/L without blood transfusion in the past 14 days.
- hemoglobin \> in the absence of blood transfusion or erythropoietin use in the last 14 days; 9g/dL;
Key exclusion criteria (32 listed)
- Nasopharyngeal or paranasal sinus cancer;
- Distant metastasis confirmed by clinical or imaging examination;
- Malignant diseases other than head and neck squamous cell carcinoma (excluding radical basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection carcinoma in situ) diagnosed within 3 years before the first dose;
- Currently participating in an interventional clinical study treatment, or receiving another study drug or using a study device within 4 weeks before the first dose;
- Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
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 |
|---|---|---|
| Adjuvant therapy: sintilimab combined with radiotherapyThe efficacy was assessed following 2 cycles of neoadjuvant therapy. Patients with efficacy evaluated as CR/PR/SD/PD underwent surgical resection. After surgical resection, sintilimab combined with radiotherapy was initiated as adjuvant therapy, and sintilimab was administered at a dosing interval of Q3W for 15 cycles. | Combination product | Chemotherapy + PD-1 inhibitor |
Primary outcome
1-year DFS rate
Time frame: 1 year
Investigator-assessed relapse-free survival at 1 year according to RECIST v1.1
6 secondary outcomes
ORR
Time frame: Six weeks after enrollment
DCR
Time frame: Six weeks after enrollment
pCR
Time frame: Six weeks after enrollment
MPR
Time frame: Six weeks after enrollment
OS
Time frame: Occurrence or end of follow-up（3 years after enrollment), which comes first
AE
Time frame: through study completion, an average of 1 year
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 30 Jan 2026.
- Individual participant dataSharing planned: No. Privacy
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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.
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 Adjuvant therapy: sintilimab combined with radiotherapy in people with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma, run by chen chao Professor 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 12 inclusion and 32 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: opening soon, as of the sponsor's last update on 30 Jan 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?
Contact Ting Jin, M.D (15968837040, jinting22222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year DFS rate (time frame: 1 year). 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 30 Jan 2026.