ClinicalTrials.gg
RecruitingNCT07781072Updated Aug 24, 2026

Sintilimab Plus Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 interventional study of Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China — 171 open to participants now, 205 under way, 25 of them phase 3. Squamous Cell Carcinoma of Head and Neck · China.

Planned enrollment
221st of 265
27 · median 68
Started
2026
with 53 others
Phase 2
139 of 290
86 open now
Primary completion
2028-06
later than 159 of 204 live
Registered
283rd of 290
by date

Among the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China, this one is the 221st largest by planned enrollment of the 265 interventional ones that give a count, is one of 54 that started in 2026, is one of 139 in phase 2, reaches primary completion later than 159 of the 204 other live ones, and was the 283rd registered.

Squamous Cell Carcinoma of Head and Neck

2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Open to participants now

171 of the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China are open now. Recruiting first, the newest first:

165 more — sign in →

All 171 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Locally Advanced Head and Neck Squamous Cell Carcinoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Provide written 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. (ECOG) performance status (PS) score of 0 or 1.

    4. 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 ).

    6. At least one measurable target lesion per 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):

    1. Hematology: (ANC) ≥1.5×10⁹/L or within normal range; count (PLT) ≥100×10⁹/L; (HGB) ≥90 g/L.
    2. Hepatic function: Total (TBIL) ≤1.5×; For subjects with Gilbert's syndrome, TBIL ≤3×ULN; For subjects without liver , and ALT ≤2.5×ULN; For subjects with liver metastasis, AST and ALT ≤5×ULN; Albumin (ALB) ≥28 g/L.
    3. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or 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).
    4. Coagulation function: (INR) ≤1.5; Activated partial thromboplastin time (APTT) ≤1.5×ULN.

      9. Male and female subjects of non , or those who agree to use at least one highly effective 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).

Exclusion criteria

Exclusion Criteria:

  • 1. History of to PD 1 agents or platinum containing components.

    2. History or concurrent presence of other (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:

    a. (NYHA) class II or higher heart failure. b. Unstable angina pectoris. c. Myocardial infarction within the past 12 months. d. supraventricular or ventricular arrhythmias requiring clinical intervention.

    4. Prior treatment history, including:

    1. Previous treatment with anti PD 1, anti PD L1, or anti CTLA 4 antibodies.
    2. Use of any drug within 4 weeks prior to the first dose of study drug.
    3. Concurrent participation in another clinical trial, unless it is an observational (non interventional) clinical study.
    4. Patients requiring systemic therapy (≥10 mg prednisone equivalent dose per day) or other 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 disease, inhaled or topical corticosteroids, or adrenal hormone replacement doses equivalent to >10 mg/day prednisone are permitted.
    5. Patients who have received anti tumor vaccines or within 4 weeks prior to the first dose of study drug.
    6. 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 (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 test result, history of acquired or congenital immunodeficiency diseases, or history of organ allotransplantation or 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 (HBV DNA ≥500 IU/mL or 2500 copies/mL) or active (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.

Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab Mai

    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.

    Combination Product: Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab

Interventions

  • Combination productHypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year from the date of enrollment

Secondary outcomes

  1. 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).

    Time frame: From enrollment to the first documented tumor response assessment

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    Time frame: From the date of enrollment until the date of death due to any cause, assessed up to 3 year.

  5. 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).

    Time frame: From enrollment to the end of treatment at 3 years.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.

Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's planned 24 months is below that.

Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 24, 2026
StartActual
Jun 12, 2026
Primary completionEst.
Jun 2028
CompletionEst.
Dec 31, 2030
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781072
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Jun 12, 2026
Primary completion
Jun 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Aug 24, 2026

Study contacts

Dongjun Dai, Doctor
Contact
daidongjunmed@zju.edu.cn
86-86992821

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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