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Head and Neck Squamous Cell CarcinomaPhase 2NCT05522985

Toripalimab-based Neoadjuvant Therapy in LA-HNSCC

A Phase 2 study testing AP combined with or without Toripalimab in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of research is to evaluate the efficacy and safety of Toripalimab combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (Toripalimab combined with AP ) and the control group (AP )… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AP combined with or without Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteChina
Study dates
2 Sep 2022to 7 Nov 2027
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

  • Age ≥ 18 years, male or female;
  • Patients with squamous cell carcinoma of head and neck confirmed by histopathology or cytopathology;
  • Surgical resection available, clinical stage III or IV without distant metastasis (AJCC 8th)
  • Patients who have not received any prior anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy or biological therapy;
  • At least one measurable lesion according to RECIST 1.1 (Appendix 1)
  • ECOG performance status 0-1 (Appendix 2);
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  • Expected survival ≥3 months;
  • Function of vital organs meets the following requirements (no blood component, cell growth factor, white blood cell-raising drug, platelet-raising drug, and blood correction drug is allowed within 14 days prior to the first dose of study drug); A.WBC≥3.0x109 /L, ANC≥2.0x109/L B.HB≥90g/L C.Platelets ≥ 100 × 10 9/L D.Serum albumin ≥2.8 g/dL E.Bilirubin total ≤ 1.5 x ULN, ALT ≤ 3.0 x ULN F.Serum creatinine ≤ 1.5xULN or Creatinine clearance > 60 mL/min G.Activated partial thromboplastin time (APTT) and International normalized ratio (INR) ≤ 1.5 x ULN (screening is allowed for stable doses of Anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants)
  • No contraindication to chemotherapy or immunotherapy;
  • No history of immune-related disease;
  • No uncontrolled pneumonia or lung infection;
  • Women of childbearing age must agree to use effective contraceptive measures during the trial; serum or urine pregnancy test must be negative within 72 hours before the first dose of study treatment;
  • Good compliance: able to receive the treatment and follow-up, and voluntary to comply with the regulations of the study;
  • Patients voluntarily sign the informed consent form.

Who cannot join

  • Patients with distant metastasis;
  • Uncontrolled severe medical diseases, e.g., severe heart disorder (New York Heart Association class II or higher; Appendix 3), cerebrovascular angiopathy, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc., combined with these medical diseases;
  • Previous history of allergy to any component of monoclonal antibody or allergic constitution;
  • Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher Cardiac failure or left ventricular Ejection fraction (LVEF) <50% as indicated by cardiac echocardiography, Angina unstable, Myocardial infarction within 1 year, patients with clinically significant supraventricular or Ventricular arrhythmia requiring clinical intervention (including QTc interval ≥ 470 ms);
  • Serious infection (NCI CTCAE > Grade 2) occurred within 4 weeks before the first dose of the study drug, such as severe pneumonia, bacteraemia, and infectious complications requiring hospitalisation; Baseline chest imaging suggests active pneumonitis, symptoms and signs of infection within 2 weeks before the first dose of the study drug, or oral or intravenous antibiotic therapy is required for treatment (excluding the use of antibiotics for prophylaxis);
  • Unexplained fever >38.5℃ occurred during the screening period and prior to the first dose (tumor fever judged by the investigator could be enrolled);
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  • Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones; type I diabetes mellitus treated with stable doses of insulin; vitiligo or healed childhood asthma/allergy that does not require any intervention after adulthood;
  • History of immunodeficiency, including HIV-positive test, or other acquired, immunodeficiency congenital diseases, or history of organ transplant and allogeneic bone marrow transplant;
  • Patients with untreated Chronic hepatitis B or chronic HBV DNA exceeding 500 IU/ml or patients with active Hepatitis C virus (HCV) should be excluded; patients with inactive Hepatitis B surface antigen who have been treated and are stable (HBV DNA<500IU/ml) and patients with cured Hepatitis C can be enrolled;
  • History of interstitial lung disease (excluding Radiation pneumonitis not induced by previous use of hormone therapy) and Noninfectious pneumonitis;
  • Patients with active pulmonary tuberculosis infection identified through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but not receiving regular treatment;
  • Patients who have received any of the following treatments:
  • A.Use of any investigational product within 4 weeks prior to the first dose of study drug B.Receiving the last dose of antitumor therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within ≤4 weeks prior to the first dose of the study drug C.Patients who require corticosteroids (daily > 10 mg prednisone equivalent dose) or other immunosuppressants for systemic treatment within 2 weeks prior to the first dose of investigational product, except for the use of corticosteroids for treatment of inflammation localised and prevention of allergic reactions and nausea and vomiting, were excluded. In the absence of active autoimmune disorder, inhaled or topical use of steroids and adrenal corticosteroid replacement with a therapeutic dose > 10 mg/day of prednisone were allowed.
  • D.Having received an antitumor vaccine or any live vaccine within 4 weeks prior to the first dose of the investigational drug E.Major surgery or serious trauma within 4 weeks prior to the first dose of study drug F.Enrollment in another clinical study
  • Dementia, mental status changes, or any psychiatric disorder that, in the Investigator's judgment, would interfere with the understanding, giving, or maintenance of informed consent or completion of the questionnaires;
  • Patients with ≥ grade 2 peripheral neuropathy according to NCI CTCAE version 5.0;
  • History of allergy or Hypersensitivity to any treatment component;
  • History of primary Neoplasm malignant other than squamous cell carcinoma of head and neck within the past 5 years, except for adequately treated basal cell or squamous epithelial skin cancer, localized prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical operation;
  • Those requiring concomitant treatment with other anti-tumor drugs;
  • Unsuitable for inclusion as determined by the investigator;
  • Pregnant or breast-feeding women

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: A Phase II, Single-center, Prospective, Randomized, Controlled Study of Induction Chemotherapy With AP Regimen Plus Anti-PD-1 Antibody JS001 (Toripalimab) for Resectable Locally Advanced Squamous Cell Carcinoma of Head and Neck

The objective of research is to evaluate the efficacy and safety of Toripalimab combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (Toripalimab combined with AP ) and the control group (AP ); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.

Being tested
AP combined with or without Toripalimab
Keywords
Head and neck squamous cell carcinoma, Neoadjuvant chemotherapy
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.

  • AP combined with or without ToripalimabDrug

    Each participant will receive AP with or without toripalimab, once every 3 weeks for a total of 3 cycles.

Study groups in NCT05522985
Study groupRoleWhat they receive
Toripalimab combined with APExperimentalNab-Paclitaxel : 260 mg/m2, intravenous infusion, d1, 3-week cycle, 3 cycles; Cisplatin: 75 mg/m2, intravenous infusion, d1, once every 3 weeks, for a total of 3 cycles; Toripalimab : 240 mg, intravenous infusion, d1, once every 3 weeks, for a total of 3 cycles.
Receives: Drug: AP combined with or without Toripalimab
AP (Nab-Paclitaxel + Cisplatin)Active comparatorNab-Paclitaxel: 260 mg/m2, intravenous infusion, d1, 3-week cycle, 3 cycles in total; Cisplatin: 75 mg/m2, intravenous infusion, d1, once every 3 weeks, for a total of 3 cycles;
Receives: Drug: AP combined with or without Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PCR

    Pathological complete response

    Measured: 12 weeks

Secondary outcomes (1)

  1. MPR

    major pathological response

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start2 Sep 2022
  3. Primary completion7 Dec 2023
  4. Study completion7 Nov 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522985
Sponsor's protocol ID
TJCIHMF&ENT-002
Status last verified
Oct 2025
First submitted
9 Aug 2022
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AP combined with or without Toripalimab in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital 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 14 inclusion and 21 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 17 Jul 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?

PCR (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05522985.

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 17 Jul 2026.

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