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Laryngeal CarcinomaPhase 3NCT06957938

Comparing Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma

A Phase 3 study testing Neoadjuvant Chemotherapy (NACT), Neoadjuvant and maintenance Tislelizumab and Concurrent chemo-radiotherapy (CCRT) in people with Laryngeal Carcinoma and Hypopharyngeal Carcinoma, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Laryngeal Carcinoma, Hypopharyngeal Carcinoma
What is being tested?
Neoadjuvant Chemotherapy (NACT), Neoadjuvant and maintenance Tislelizumab and Concurrent chemo-radiotherapy (CCRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteChina
Study dates
28 Apr 2025to 1 May 2031
Phase
Phase 3
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

  • Patients who have signed the informed consent form and are willing to complete the study according to the protocol.
  • Age ≥18 years and ≤75 years.
  • Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx.
  • Locally advanced laryngeal or hypopharyngeal cancer that requires total laryngectomy and is amenable to total laryngectomy according to surgical assessment.
  • At least one measurable lesion before treatment, which meets the criteria for "measurable lesion" according to RECIST 1.1 criteria.
  • An expected survival of >3 months.
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  • ECOG performance status of 0-1.
  • Adequate organ function, meeting the following requirements:
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L;
  • Platelet count ≥100×10^9/L;
  • Hemoglobin ≥9 g/dL;
  • Serum albumin ≥2.8 g/dL;
  • Total bilirubin ≤1.5×ULN, ALT, AST, and/or ALP ≤3×ULN;
  • Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault, see Appendix III);
  • Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients on stable doses of anticoagulant therapy, such as low-molecular-weight heparin or warfarin, with INR within the therapeutic range of the anticoagulant, are eligible).
  • Patients with hepatitis B virus (HBV) infection, as well as inactive/asymptomatic HBV carriers, or those with chronic or active HBV, will be allowed to enroll if HBV DNA <500 IU/mL (or 2500 copies/mL) at screening. Patients who are positive for hepatitis C antibody will be allowed to enroll if HCV-RNA is negative at screening.
  • Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days before treatment. They must also agree to use an accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period, as well as for at least 3 months after the last dose of PD-1 inhibitor and at least 6 months after the last dose of chemotherapy.
  • Male subjects who have not been sterilized must agree to use an accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period, as well as for at least 3 months after the last dose of PD-1 inhibitor and at least 6 months after the last dose of chemotherapy.

Who cannot join

  • Patients who have been confirmed to have distant metastasis on imaging assessment before treatment.
  • Patients who have previously received immune checkpoint inhibitor therapy.
  • Patients who have previously received radiotherapy to the head and neck region.
  • Patients who have had or currently have other malignancies (except for malignancies that have been cured and have been cancer-free for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer); if a patient has both hypopharyngeal cancer and esophageal cancer, and the esophageal lesion and hypopharyngeal lesion are anatomically non-adjacent, they should be diagnosed with multiple primary tumors and will not be eligible for enrollment.
  • Uncontrolled cardiac symptoms or diseases, such as: a. NYHA Class II or higher heart failure; b. unstable angina; c. myocardial infarction within the past year; d. clinically significant supraventricular or ventricular arrhythmias that are not well controlled with medication.
  • Patients who have received any of the following treatments:
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  • Received any investigational drug within 4 weeks before the first dose of the study drug.
  • Enrolled in another clinical study concurrently, unless it is an observational (non-interventional) clinical study.
  • Require systemic treatment with corticosteroids (more than 10 mg prednisone equivalent per day) or other immunosuppressive agents within 2 weeks before the first dose of the study drug, except for corticosteroids used for local inflammation and prevention of allergies and nausea/vomiting. Other special circumstances should be discussed with the investigator. In the absence of active autoimmune disease, the use of inhaled or topical steroids and adrenal corticosteroid replacement at doses greater than 10 mg/day prednisone equivalent is permitted.
  • Received anti-tumor vaccines or live vaccines within 4 weeks before the first dose of the study drug (if the patient has received a COVID-19 vaccine, the interval between vaccination and treatment should be more than 2 weeks).
  • Underwent major surgery or had a severe injury within 4 weeks before the first dose of the study drug.
  • Patients who have had a severe infection (CTCAE > Grade 2) within 4 weeks before the first dose of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging showing active pulmonary inflammation; symptoms and signs of infection within 4 weeks before the first dose of the study drug or requiring oral or intravenous antibiotic treatment.
  • Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); however, this does not include autoimmune hypothyroidism treated with a stable dose of thyroid hormone replacement therapy; type 1 diabetes treated with a stable dose of insulin; vitiligo or childhood asthma/allergies that have healed and do not require any intervention in adulthood.
  • Patients with a history of immunodeficiency, including positive HIV test results, or those with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation.
  • Patients with a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with corticosteroids) or non-infectious pneumonia.
  • Patients with active tuberculosis infection identified through history or CT scan, or those with a history of active tuberculosis infection within 1 year before enrollment, or those with a history of active tuberculosis infection more than 1 year ago that was not properly treated.
  • Patients with active hepatitis B (HBV DNA ≥500 IU/mL or 2500 copies/mL) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).
  • Patients with a known history of abuse of psychoactive drugs, alcoholism, or drug addiction.
  • Pregnant or breastfeeding women.
  • Patients who, in the investigator's judgment, have other factors that may force them to discontinue the study prematurely, such as having other serious diseases (including mental illnesses) requiring concurrent treatment, severely abnormal laboratory values, family or social factors, or conditions that may affect the patient's safety or the collection of trial data.

Trial locations and contacts

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

Yu Wang, M.D., professor contact

+86-18017312437

neck130@hotmail.com

Xiaomin Ou, M.D. contact

+86-18017317872

xiaomin_ou@fudan.edu.cn

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiaomin Ou, M.D., xiaomin_ou@fudan.edu.cn

    Yu Wang, M.D., professor, Chief

Other trials in China

About this study

Official title: A Prospective, Multi-centered, Randomized Phase III Study to Compare Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma

Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear.

Thus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.

Being tested
Neoadjuvant Chemotherapy (NACT), Neoadjuvant and maintenance Tislelizumab, Concurrent chemo-radiotherapy (CCRT), Surgery and adjuvant (chemo-)radiotherapy
Keywords
Neoadjuvant chemotherapy, Induction chemotherapy, Immunotherapy, anti-PD-1 antibody, PD-1 inhibitor, Tislelizumab, surgery, radiation, Locally advanced disease, Laryngeal preservation, Laryngeal cancer, Hypopharyngeal cancer, Head and neck cancer, Head and neck squamous cell carcinoma
Medical subject headings
Laryngeal Neoplasms, Hypopharyngeal Neoplasms, Head and Neck Neoplasms, 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.

  • Neoadjuvant Chemotherapy (NACT)Drug

    Neoadjuvant Chemotherapy with paclitaxel (or albumin - bound paclitaxel) and cisplatin

  • Neoadjuvant and maintenance TislelizumabDrug

    Neoadjuvant and maintenance Tislelizumab

  • Concurrent chemo-radiotherapy (CCRT)Radiation

    Concurrent chemo-radiotherapy (CCRT), with cisplatin-based chemotherapy

  • Surgery and adjuvant (chemo-)radiotherapyProcedure or surgery

    Definitive surgery, with adjuvant (chemo-)radiotherapy, depending on pathologic findings.

Study groups in NCT06957938
Study groupRoleWhat they receive
Neoadjuvant chemotherapy combined with TislelizumabExperimentalNeoadjuvant chemotherapy combined with Tislelizumab, followed by chemo-radiation or surgery and adjuvant (chemo-)radiation, then maintenance therapy of Tislelizumab.
Receives: Drug: Neoadjuvant Chemotherapy (NACT); Drug: Neoadjuvant and maintenance Tislelizumab; Radiation: Concurrent chemo-radiotherapy (CCRT); Procedure: Surgery and adjuvant (chemo-)radiotherapy
Neoadjuvant chemotherapyActive comparatorNeoadjuvant chemotherapy, followed by chemo-radiation or surgery and adjuvant (chemo-)radiation.
Receives: Drug: Neoadjuvant Chemotherapy (NACT); Radiation: Concurrent chemo-radiotherapy (CCRT); Procedure: Surgery and adjuvant (chemo-)radiotherapy

What is being measured

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

  1. 2-year Laryngectomy-free Survival Rate

    Laryngectomy-free survival (LFS) is defined as the time from randomization to the first occurrence of local recurrence, total laryngectomy, or death, with the time calculated based on the first event that occurs.

    Measured: 2 year

Secondary outcomes (9)

  1. Early response rate

    Early response rate is defined as the proportion of patients achieving a complete response [CR] or partial response [PR] in the primary tumor after one cycle of neoadjuvant therapy

    Measured: day 14 to day 21

  2. Objective response rate to neoadjuvant therapy

    Objective response rate to neoadjuvant therapy is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) in the primary tumor and cervical lymph nodes after three cycles of neoadjuvant therapy.

    Measured: day 56 to day 63

  3. 2-year Event-free Survival Rate

    Event-free survival (EFS), defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local recurrence, distant metastasis, or death from any cause, whichever occurs first.

    Measured: 2 year

  4. 2-year Overall Survival Rate

    Overall Survival (OS), defined as the time from randomization to death from any cause.

    Measured: 2 year

  5. 2-year Laryngectomy-free Survival Rate with a functional larynx

    Laryngectomy-free survival with a functional larynx (fLFS), defined as the time from randomization to the occurrence of an endpoint event, which includes: evidence of local recurrence; total laryngectomy; death; or survival at 2 years with tracheostomy, nasogastric tube, or gastrostomy.

    Measured: 2 year

  6. 2-year Local Recurrence-Free Survival Rate

    Local Recurrence-Free Survival (LRFS): Defined as the time from randomization to the first documentation of local recurrence or to death from any cause.

    Measured: 2 year

  7. 2-year Distant Metastasis-Free Survival Rate

    Distant Metastasis-Free Survival (DMFS): Defined as the time from randomization to the first documentation of distant metastasis or to death from any cause, whichever occurs first.

    Measured: 2 year

  8. Adverse event

    Adverse events, defined as any untoward medical occurrence in a clinical trial subject after randomization up to 2 years post-randomization, which does not necessarily have a causal relationship with the treatment.

    Measured: 2 year

  9. Quality of life

    Quality of life, assessed based on disease-related symptoms and quality of life using the EORTC Quality of Life Questionnaire Head and Neck (H\&N)-35 score. For scores related to speech and swallowing function, the higher score indicates more severe symptom.

    Measured: 2 year

Timeline

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

  1. First posted6 May 2025
  2. Study start28 Apr 2025 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957938
Sponsor's protocol ID
PRECEDE
Other IDs
2504318-4
Status last verified
Apr 2025
First submitted
27 Apr 2025
Last updated
8 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Fang Q, Xu P, Cao F, Wu D, Liu X. PD-1 Inhibitors combined with paclitaxel (Albumin-bound) and cisplatin for larynx preservation in locally advanced laryngeal and hypopharyngeal squamous cell carcinoma: a retrospective study. Cancer Immunol Immunother. 2023 Dec;72(12):4161-4168. doi: 10.1007/s00262-023-03550-z. Epub 2023 Oct 7.

    PubMed 37804437

  • Ou X, Zhai R, Wei W, Chen J, Ou D, Liao T, Xu T, Zhu Y, Wang Y, Huang S, Shi R, Wu B, Chen T, Li Y, Yang Z, Zhou C, Liu Y, Jiang Z, Zeng M, Liu X, Ji D, Ying H, Zhang Z, Hu C, Lu X, Ji Q, He X, Wang Y. Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial. Clin Cancer Res. 2024 Jan 17;30(2):344-355. doi: 10.1158/1078-0432.CCR-23-2398.

    PubMed 37955629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant Chemotherapy (NACT), Neoadjuvant and maintenance Tislelizumab and Concurrent chemo-radiotherapy (CCRT) in people with Laryngeal Carcinoma and Hypopharyngeal Carcinoma, run by Fudan University 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 18 inclusion and 20 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 8 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yu Wang, M.D., professor (+86-18017312437, neck130@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Laryngectomy-free Survival Rate (time frame: 2 year). 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 NCT06957938, which also lists 2 linked publications.

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 8 May 2025.

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