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Locally Advanced Hypopharyngeal CancerPhase 2NCT07137039

Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen

A Phase 2 study testing Adebrelimab+Albumin paclitaxel +Cisplatin in people with Locally Advanced Hypopharyngeal Cancer, run by The First Affiliated Hospital of Xiamen 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

To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Locally Advanced Hypopharyngeal Cancer
What is being tested?
Adebrelimab+Albumin paclitaxel +Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
20 Aug 2025to 20 Aug 2028
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age: 18 to 70 years old, gender not limited;
  • 2.ECOG PS score: 0-1 point;
  • 3. Patients who are capable of surgical resection and willing to undergo it;
  • 4. Hypopharyngeal cancer diagnosed by histology/cytology and imaging, with a clinical stage of T1-2, N1-3 or T3-4, any N;
  • 5. At least one measurable lesion (in accordance with RECIST 1.1 standard);
  • 6. The expected survival period is at least 12 weeks;
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  • 7. Other major organs (liver, kidneys, blood system, etc.) function well: Hemoglobin ≥90g/L (no blood transfusion, no use of hematopoietic factors and no drug correction within 2 weeks before the first administration); Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin ≤1.5 times the upper limit of the normal value; Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase ≤2.5 times the upper limit of the normal value; Serum creatinine ≤1.5 times the upper limit of the normal value, and endogenous creatinine clearance rate ≥60ml/min; For patients who have not received anticoagulant therapy, the international normalized ratio of prothrombin time (INR) is ≤1.5, and the activated partial thromboplastin time (APTT) is ≤1.5 times the upper limit of the normal value.
  • 8. Female subjects with fertility must undergo a pregnancy test (serum or urine) within 72 hours before the start of the study medication, and the result must be negative. They must also be willing to use a medically approved efficient contraceptive measure (such as an intrauterine device, contraceptive pill or condom) during the study period and within 90 days after the last administration of the study drug. For male subjects whose partners are women of childbearing age, they must agree to use effective contraception or have undergone surgical sterilization during the study period and within 90 days after the last administration of the study.
  • 9. There is no history of allergy to related drug components.
  • 10. The subjects voluntarily joined this clinical study and signed the informed consent form.

Who cannot join

  • 1. Have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine anti-tumor treatment (except for the treatment of malignant tumors that have been completely cured in the past and have no recurrence or metastasis for ≥5 years);
  • 2. Have undergone surgical operations targeting the primary tumor or lymph nodes in the past;
  • 3. Patients who have suffered from any malignant tumors in the past five years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
  • 4. Patients with distant metastases;
  • 5. Suffering from any active autoimmune disease or a history of autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis) Patients with childhood asthma that has been completely relieved and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis or alopecia) can be included. However, patients who need medical intervention with bronchodilators cannot be included.
  • 6. Subjects who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones >10 mg/ day) or other immunosuppressants within 2 weeks prior to the first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids, as well as adrenal hormone replacement therapy with a dose of ≤10 mg/ day at the therapeutic dose of prednisone, is permitted.
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  • 7. Those who have experienced hyperactive or venous thrombosis events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
  • 8. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., have occurred, or are currently receiving thrombolytic or anticoagulant therapy;
  • 9. Those with hypertension who have not achieved good control through antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women); According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography;
  • 10. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein content ≥1g, or severe liver and kidney dysfunction;
  • 11. Allergic to the test drug;
  • 12. Known human immunodeficiency virus (HIV) infection;
  • 13. Pregnant or lactating women; Subjects with fertility who are unwilling or unable to take effective contraceptive measures;
  • 14. Those who suffer from neurological or mental disorders and are unable to cooperate;
  • 15. Other circumstances that the researchers consider unsuitable for inclusion.

Trial locations and contacts

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

Sangang Wu contact

15960208092

wusg@xmu.edu.xn

China1 site

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Sangang Wu, MD, 865922139531, wusg@xmu.edu.cn

Other trials in China

About this study

Official title: A Single-arm, Prospective, Single-center Clinical Study on Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen

To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer

Being tested
Adebrelimab+Albumin paclitaxel +Cisplatin
Keywords
hypopharyngeal cancer, neoadjuvant treatment, adebrelimab, chemotherapy
Medical subject headings
Hypopharyngeal Neoplasms

What participants receive

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

  • Adebrelimab+Albumin paclitaxel +CisplatinDrug

    1. Adebrelimab：1200mg, ivgtt, D1, Q3W;
    2. Albumin paclitaxel :260mg/m2, ivgtt, D1, Q3W;
    3. Cisplatin :60mg/m2, ivgtt, D1, Q3W.
Study groups in NCT07137039
Study groupRoleWhat they receive
Experimental groupExperimentalAdebrelimab combined with albumin, paclitaxel and cisplatin
Receives: Drug: Adebrelimab+Albumin paclitaxel +Cisplatin

What is being measured

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

  1. Pathological complete response (pCR)

    Pathological examination of the resected tissue samples did not reveal any residual tumor cells.

    Measured: Six months

Secondary outcomes (9)

  1. Major pathological response (MPR)

    Major pathological response (MPR) is defined as the presence of active tumor tissue in surgical specimens ≤10% at the time of tumor resection.

    Measured: six months

  2. Surgical R0 resection rate

    The proportion of the resection margin without residual cancer cells

    Measured: Six months

  3. Laryngeal function retention rate

    It refers to the proportion of subjects whose laryngeal functions (including vocalization, breathing and swallowing functions) are successfully preserved during the treatment process through methods such as surgery, radiotherapy, chemotherapy or comprehensive treatment.

    Measured: six months

  4. The intensity of the surgery has decreased

    The researchers determined whether the surgical intensity had decreased based on the subjects' conditions.

    Measured: six months

  5. Objective response rate (ORR)

    It refers to the proportion of all subjects whose best overall response (BOR) was rated as complete response (CR) or partial response (PR) according to the RECIST 1.1 standard.

    Measured: one year

  6. Disease Control rate (DCR)

    It refers to the proportion of all subjects whose overall response rate (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to the RECIST 1.1 standard.

    Measured: One year

  7. Recurrence-free survival time (RFS)

    It refers to the period from the date of successful surgery to recurrence or death.

    Measured: Two years

  8. Overall survival (OS)

    Defined as the period from the date of the first administration to the death of the subject for various reasons.

    Measured: Two years

  9. Adverse event(AE)

    The incidence and severity of adverse events (AE) evaluated according to CTCAE 5.0

    Measured: Two years

Timeline

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

  1. First posted22 Aug 2025
  2. Study start20 Aug 2025 (estimated)
  3. Primary completion20 Aug 2027 (estimated)
  4. Study completion20 Aug 2028 (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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137039
Sponsor's protocol ID
XMHNC-001
Status last verified
Aug 2025
First submitted
15 Aug 2025
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab+Albumin paclitaxel +Cisplatin in people with Locally Advanced Hypopharyngeal Cancer, run by The First Affiliated Hospital of Xiamen 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 10 inclusion and 15 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 22 Aug 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 Sangang Wu (15960208092, wusg@xmu.edu.xn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: Six months). 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 NCT07137039.

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 22 Aug 2025.

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