Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT07781072
Sintilimab Plus Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still associated with a high rate of disease recurrence. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 31 Dec 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Provide written informed consent and understand and agree to comply with study requirements and the study visit schedule.
- 2. Male or female subjects aged ≥18 and ≤75 years at the time of signing the informed consent form.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- 4. Histologically or cytologically confirmed stage III IVB head and neck squamous cell carcinoma as assessed by the investigator.
- 5. No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti PD 1 or anti PD L1 antibodies, anti CTLA 4 antibodies and other immune checkpoint inhibitors).
- 6. At least one measurable target lesion per RECIST version 1.1 criteria. 7. Expected survival time ≥12 weeks. 8. Adequate bone marrow and organ function (no administration of any cellular/blood components, colony stimulating factors or cytokines within 14 days prior to laboratory testing):
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- Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L or within normal range; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥90 g/L.
- Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN; For subjects with Gilbert's syndrome, TBIL ≤3×ULN; For subjects without liver metastasis, AST and ALT ≤2.5×ULN; For subjects with liver metastasis, AST and ALT ≤5×ULN; Albumin (ALB) ≥28 g/L.
- Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (CCR) ≥60 mL/min (calculated by Cockcroft Gault formula or measured via 24 hour urine collection); Urinalysis showing urinary protein <2+. Subjects with baseline urinary protein ≥2+ must undergo 24 hour urine collection with 24 hour urinary protein <1 g (if both assays are performed, the 24 hour urine result will be used for eligibility determination).
- Coagulation function: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (APTT) ≤1.5×ULN.
- 9. Male and female subjects of non childbearing potential, or those who agree to use at least one highly effective contraceptive method during the study (starting 14 days prior to screening or first study drug administration, whichever occurs earlier, continuing for 180 days after the last dose of study drug).
Who cannot join
- 1. History of hypersensitivity to PD 1 agents or platinum containing components.
- 2. History or concurrent presence of other malignancies (except for malignancies cured with no relapse for more than 5 years, including basal cell carcinoma, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
- 3. Uncontrolled clinical cardiac symptoms or diseases, including:
- New York Heart Association (NYHA) class II or higher heart failure. b. Unstable angina pectoris. c. Myocardial infarction within the past 12 months. d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- 4. Prior treatment history, including:
- Previous treatment with anti PD 1, anti PD L1, or anti CTLA 4 antibodies.
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- Use of any investigational drug within 4 weeks prior to the first dose of study drug.
- Concurrent participation in another clinical trial, unless it is an observational (non interventional) clinical study.
- Patients requiring systemic corticosteroid therapy (≥10 mg prednisone equivalent dose per day) or other immunosuppressive agents within 2 weeks before the first dose of study drug, except for local inflammation, hypersensitivity, and prophylaxis for nausea and vomiting. Other special situations should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroids, or adrenal hormone replacement doses equivalent to >10 mg/day prednisone are permitted.
- Patients who have received anti tumor vaccines or live vaccines within 4 weeks prior to the first dose of study drug.
- Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of study drug.
- 5. Not recovered to ≤ Grade 1 from previous anti tumor therapy according to Common Terminology Criteria for Adverse Events (CTCAE) (alopecia and residual neuropathy related to prior platinum based therapy are excluded), or failing to meet the levels specified in inclusion/exclusion criteria.
- 6. Severe infection (CTCAE grade >2) within 4 weeks prior to the first dose of study drug, including severe pneumonia, bacteremia, complicated infections requiring hospitalization, active pulmonary inflammation on baseline chest imaging, infectious signs and symptoms within 4 weeks before first study drug administration, or infections requiring oral or intravenous antibiotic therapy.
- 7. Active autoimmune disease or history of autoimmune disease (such as interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes). However, patients with autoimmune hypothyroidism receiving stable dose thyroid hormone replacement and patients with type 1 diabetes mellitus treated with stable dose insulin are not excluded. Patients with vitiligo or childhood onset asthma/hypersensitivity that resolves without intervention in adulthood are also eligible.
- 8. History of immunodeficiency, including positive HIV test result, history of acquired or congenital immunodeficiency diseases, or history of organ allotransplantation or allogeneic bone marrow transplantation.
- 9. History of interstitial lung disease (excluding radiation pneumonitis that has not received corticosteroid therapy) or non infectious pneumonitis.
- 10. Evidence of active tuberculosis infection based on medical history or CT scan; active tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis more than 1 year previously without standard of care treatment.
- 11. Patients with active hepatitis B (HBV DNA ≥500 IU/mL or 2500 copies/mL) or active hepatitis C (anti HCV positive with HCV RNA above the lower limit of detection).
- 12. History of substance abuse, alcohol abuse, or drug addiction. 13. Pregnant or lactating women. 14. Subjects with other factors that, in the investigator's opinion, may lead to premature study termination, such as other severe concurrent illnesses (including psychiatric disorders), significant laboratory abnormalities, family or social factors that may compromise subject safety or data collection.
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, 1 recruiting
- Recruiting
Second Affiliated Hospital Of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Dongjun Dai, Doctor, 86-86992821, daidongjunmed@zju.edu.cn
About this study
Official title: Sintilimab Combined With Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study
Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still associated with a high rate of disease recurrence. Given the relatively high mutational burden of HNSCC, immunotherapy has emerged as a promising therapeutic strategy. The addition of PD-1 inhibitors to induction chemotherapy has been shown to improve antitumor responses without increasing treatment-related toxicity. In addition, radiotherapy can further potentiate systemic antitumor immune responses.
Sintilimab, a PD-1 monoclonal antibody, has demonstrated robust antitumor activity across multiple solid malignancies. Early clinical evidence indicates a synergistic antitumor effect when combined with hypofractionated radiotherapy. Nevertheless, clinical data regarding the combination of sintilimab with chemoradiotherapy in locally advanced HNSCC remain limited.
Accordingly, we designed a multicenter, single-arm phase II trial to evaluate the efficacy and safety of sintilimab in combination with definitive chemoradiotherapy for patients with locally advanced HNSCC.
- Being tested
- Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and SintilimabCombination product
Induction therapy consists of two cycles of sintilimab injection combined with hypofractionated radiotherapy (5 Gy × 3), followed by sequential concurrent chemoradiotherapy delivered at 50 Gy in 25 fractions with two cycles of platinum-based chemotherapy (cisplatin, nedaplatin or carboplatin). Upon completion of chemoradiotherapy, patients are administered maintenance sintilimab injection for a minimum of six months.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab Mai | Experimental | Induction therapy consists of two cycles of sintilimab injection combined with hypofractionated radiotherapy (5 Gy × 3), followed by sequential concurrent chemoradiotherapy delivered at 50 Gy in 25 fractions with two cycles of platinum-based chemotherapy. Upon completion of chemoradiotherapy, patients are administered maintenance sintilimab injection for a minimum of six months. Receives: Combination Product: Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival rate (1-year PFS rate)
The proportion of patients who remain alive without disease progression (including local recurrence, regional recurrence, distant metastasis, or death) one year after the start of treatment.
Measured: 1 year from the date of enrollment
Secondary outcomes (5)
Objective Response Rate (ORR)
Objective Response Rate (ORR) refers to the proportion of patients who achieve a measurable reduction in tumor burden, specifically those who experience a complete response (CR) or partial response (PR) according to standardized criteria (such as RECIST).
Measured: From enrollment to the first documented tumor response assessment
Progression-free survival(PFS)
Progression-free survival is the length of time from the start of treatment (or from randomization/enrollment) until the disease progresses or the patient dies from any cause, whichever occurs first.
Measured: From the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 year.
Distant Metastasis-Free Survival (DMFS)
Distant Metastasis-Free Survival (DMFS) is the length of time from the start of treatment (or from diagnosis/enrollment) until the first occurrence of distant metastasis or death from any cause, whichever happens first.
Measured: From the date of enrollment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to 3 year.
Overall Survival(OS)
Overall Survival(OS) is defined as the period from the date of first treatment administration to the date of death due to any cause.
Measured: From the date of enrollment until the date of death due to any cause, assessed up to 3 year.
Adverse events.
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
Measured: From enrollment to the end of treatment at 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start12 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781072
- Sponsor's protocol ID
- 2025-1923
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07781072
- Acronym / sponsor ID
- 2025-1923
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Aug 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.
Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still associated with a high rate of disease recurrence. Given the relatively high mutational burden of HNSCC, immunotherapy has emerged as a promising therapeutic strategy. The addition of PD-1 inhibitors to induction chemotherapy has been shown to improve antitumor responses without increasing treatment-related toxicity. In addition, radiotherapy can further potentiate systemic antitumor immune responses.
Sintilimab, a PD-1 monoclonal antibody, has demonstrated robust antitumor activity across multiple solid malignancies. Early clinical evidence indicates a synergistic antitumor effect when combined with hypofractionated radiotherapy. Nevertheless, clinical data regarding the combination of sintilimab with chemoradiotherapy in locally advanced HNSCC remain limited.
Accordingly, we designed a multicenter, single-arm phase II trial to evaluate the efficacy and safety of sintilimab in combination with definitive chemoradiotherapy for patients with locally advanced HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab Mai | Experimental | Combination Product: Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and SintilimabInduction therapy consists of two cycles of sintilimab injection combined with hypofractionated radiotherapy (5 Gy × 3), followed by sequential concurrent chemoradiotherapy delivered at 50 Gy in 25 fractions with two cycles of platinum-based chemotherapy. Upon completion of chemoradiotherapy, patients are administered maintenance sintilimab injection for a minimum of six months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Provide written informed consent and understand and agree to comply with study requirements and the study visit schedule.
- 2. Male or female subjects aged ≥18 and ≤75 years at the time of signing the informed consent form.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- 4. Histologically or cytologically confirmed stage III IVB head and neck squamous cell carcinoma as assessed by the investigator.
- 5. No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti PD 1 or anti PD L1 antibodies, anti CTLA 4 antibodies and other immune checkpoint inhibitors).
Key exclusion criteria (19 listed)
- 1. History of hypersensitivity to PD 1 agents or platinum containing components.
- 2. History or concurrent presence of other malignancies (except for malignancies cured with no relapse for more than 5 years, including basal cell carcinoma, carcinoma in situ of the cervix, and papillary thyroid carcinoma).
- 5. Not recovered to ≤ Grade 1 from previous anti tumor therapy according to Common Terminology Criteria for Adverse Events (CTCAE) (alopecia and residual neuropathy related to prior platinum based therapy are excluded), or failing to meet the levels specified in inclusion/exclusion criteria.
- 6. Severe infection (CTCAE grade >2) within 4 weeks prior to the first dose of study drug, including severe pneumonia, bacteremia, complicated infections requiring hospitalization, active pulmonary inflammation on baseline chest imaging, infectious signs and symptoms within 4 weeks before first study drug administration, or infections requiring oral or intravenous antibiotic therapy.
- 7. Active autoimmune disease or history of autoimmune disease (such as interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes). However, patients with autoimmune hypothyroidism receiving stable dose thyroid hormone replacement and patients with type 1 diabetes mellitus treated with stable dose insulin are not excluded. Patients with vitiligo or childhood onset asthma/hypersensitivity that resolves without intervention in adulthood are also eligible.
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 |
|---|---|---|
| Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and SintilimabInduction therapy consists of two cycles of sintilimab injection combined with hypofractionated radiotherapy (5 Gy × 3), followed by sequential concurrent chemoradiotherapy delivered at 50 Gy in 25 fractions with two cycles of platinum-based chemotherapy (cisplatin, nedaplatin or carboplatin). Upon completion of chemoradiotherapy, patients are administered maintenance sintilimab injection for a minimum of six months. | Combination product | Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab Mai |
Primary outcome
1-year progression-free survival rate (1-year PFS rate)
Time frame: 1 year from the date of enrollment
The proportion of patients who remain alive without disease progression (including local recurrence, regional recurrence, distant metastasis, or death) one year after the start of treatment.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: From enrollment to the first documented tumor response assessment
Progression-free survival(PFS)
Time frame: From the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 year.
Distant Metastasis-Free Survival (DMFS)
Time frame: From the date of enrollment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to 3 year.
Overall Survival(OS)
Time frame: From the date of enrollment until the date of death due to any cause, assessed up to 3 year.
Adverse events.
Time frame: From enrollment to the end of treatment at 3 years.
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 24 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.
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 Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 24 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?
Contact Dongjun Dai, Doctor (86-86992821, daidongjunmed@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival rate (1-year PFS rate) (time frame: 1 year from the date of enrollment). 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 24 Aug 2026.