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Head and Neck TumorsPhase 2NCT05758389

Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

A Phase 2 study testing Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU in people with Head and Neck Tumors, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Tumors
What is being tested?
Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
1 Apr 2022to 7 Dec 2025
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

  • Age 18-75 years old;
  • Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.;
  • Have at least one radiographically measurable lesion (RECIST 1.1 criteria);
  • The clinical stage is III-IVb (P16-) or II-III (P16+);
  • There are tumor samples that can detect gene expression;
  • ECOG score 0-1 points;
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  • Have not received radiotherapy and chemotherapy or other anti-tumor drugs before;
  • The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L
  • The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT < 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5xULN (for anticoagulation at a stable dose such as low molecular weight heparin or warfar.) LIN and INR can be screened within the expected therapeutic range of anticoagulants)
  • Subjects of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control);
  • Have signed informed consent;
  • Ability to follow study protocols and follow-up procedures.

Who cannot join

  • Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait;
  • Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.);
  • There is distant metastasis;
  • Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood;
  • Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation);
  • Severe infection (CTC AE>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging examination showed active lung Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics);
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  • The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) < 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible;
  • Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA<500IU/ml), and cured hepatitis C patients can be enrolled;
  • Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia;
  • Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment;
  • Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone >10 mg/day is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time;
  • Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative;
  • Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences;
  • Those who may be allergic to the study drug;
  • Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors;
  • Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%);
  • Any uncertain factors affecting the safety or compliance of the subjects;
  • Contraindications to hormone use.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Yan contact

+86 15805182426

firefreebird@163.com

Kongcheng Wang contact

+86 13814165197

wangxxbz@126.com

China1 site, 1 recruiting

  • Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine

    Nanjing, Jiangsu

    Jing Yan, +86 15805182426, firefreebird@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Single-center, Single-arm Clinical Study of the PD-1 Inhibitor Tislelizumab Combined With APF Sequential Surgery or Radical Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Head and Neck Tumors

The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are:

  1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors.
  2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.
Being tested
Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU
Keywords
Immune checkpoint inhibitors, Chemotherapy, Locally advanced head and neck tumors, Induction therapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FUDrug

    evaluate the efficacy and safety of immunotherapy combined with chemotherapy

Study groups in NCT05758389
Study groupRoleWhat they receive
immunotherapy combined with chemotherapyExperimentalNot described
Receives: Drug: Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU

What is being measured

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

  1. Change of pathological examination

    Changes in pathologic examination before treatment and after 3-cycle induction therapy were evaluated to derive the number and proportion of patients with pathological complete remission

    Measured: Change from Baseline pathologic examination at the end of Cycle 3 (each cycle is 21 days)

  2. Change of tumor size

    imaging (MRI or CT) assessment according to RECIST v1.1 was performed and documented during follow-up as required

    Measured: Change from baseline tumor size at the end of Cycle 3 (each cycle is 21 days)

Secondary outcomes (1)

  1. Security assessment

    according to the NCI-CTCAE 4.0 adverse reaction evaluation criteria

    Measured: At the end of Cycle 3 (each cycle is 21 days)

Timeline

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

  1. First posted7 Mar 2023
  2. Study start1 Apr 2022
  3. Primary completion7 Aug 2025
  4. Study completion7 Dec 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05758389
Sponsor's protocol ID
2021-666-02
Status last verified
Aug 2025
First submitted
17 Jan 2023
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU in people with Head and Neck Tumors, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 18 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 5 Sep 2025. 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 Jing Yan (+86 15805182426, firefreebird@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of pathological examination (time frame: Change from Baseline pathologic examination at the end of Cycle 3 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 NCT05758389.

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 5 Sep 2025.

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