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Squamous Cell Carcinoma of Head and NeckPhase 2NCT07055841

Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Adebrelimab, TP regimen and Surgery or radiotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by Xiuping Ding 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

This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Adebrelimab, TP regimen and Surgery or radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
1 Apr 2023to 1 Aug 2026
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients with head and neck squamous cell carcinoma diagnosed by histology or cytology;
  • 2. Have not received systematic treatment for head and neck squamous cell carcinoma in the past;
  • 3. According to the AJCC TNM staging system, it is divided into stages III-IVB;
  • 4. ECOG score: 0-1 point;
  • 5. Expected survival period ≥ 12 weeks;
  • 6. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
  • 7. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period, at least 6 months after the last use of adebelimab, and at least 6 months after the last use of chemotherapy;
  • 8. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Who cannot join

  • 1. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
  • 2. Have a history of allergies to any components of Adabelimab in the past;
  • 3. Have received any of the following treatments:
  • Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
  • Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
  • Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
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  • Subjects who need to receive corticosteroids (equivalent to>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
  • Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
  • Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
  • Patients who have received previous treatment with paclitaxel drugs;
  • 4. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/exclusion criteria;
  • 5. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
  • 6. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);
  • 7. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
  • 8.Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous administration Or intravenous use of antibiotics for treatment, except for prophylactic use of antibiotics;
  • 9. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
  • 10. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
  • 11. Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;
  • 12. Pregnant or lactating women;
  • 13. According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject'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.

Xiuping Ding, Dr. contact

+86 18654539599

drdxp85@126.com

China1 site, 1 recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Xiuping Ding, Dr, 18654539599, drdxp85@126.com

    Recruiting

Other trials in China

About this study

This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.

Being tested
Adebrelimab, TP regimen, Surgery or radiotherapy
Keywords
PD-L1, Local late stage
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.

  • AdebrelimabDrug

    1200mg, intravenous infusion, D1， Every three weeks, there are two cycles in total.

  • TP regimenDrug

    TP regimen: Docetaxel 75 mg/m2, intravenous infusion, D1， Cisplatin 75 mg/m2, intravenous infusion, D1， Every three weeks, there are two cycles in total.

  • Surgery or radiotherapyProcedure or surgery

    Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.

Study groups in NCT07055841
Study groupRoleWhat they receive
Group 1ExperimentalTP regimen Adbelimab Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.
Receives: Drug: Adebrelimab; Drug: TP regimen; Procedure: Surgery or radiotherapy

What is being measured

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

  1. ORR

    Objective response rate (ORR)

    Measured: From enrollment to first efficacy evaluation (around 6-8 weeks)

Secondary outcomes (4)

  1. pCR

    pathological complete response，pCR

    Measured: Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery

  2. R0 resection rate

    R0 is the ratio of no residual material under the microscope after resection.

    Measured: Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery

  3. EFS

    Event-Free Survival（EFS）

    Measured: The time from enrollment to the first occurrence of endpoint events such as disease progression and death(maximum follow-up time of 2 years)

  4. Adverse event incidence rate

    Adverse events that occurred during the research process

    Measured: Follow up from enrollment until 90 days after the last treatment

Timeline

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

  1. First posted9 Jul 2025
  2. Study start1 Apr 2023
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2026 (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
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07055841
Sponsor's protocol ID
23-OBU-SD-HNC-II-003
Status last verified
Jun 2025
First submitted
18 Jun 2025
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
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, TP regimen and Surgery or radiotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by Xiuping Ding 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 8 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: looking for participants now, as of the sponsor's last update on 9 Jul 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 Xiuping Ding, Dr. (+86 18654539599, drdxp85@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From enrollment to first efficacy evaluation (around 6-8 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 NCT07055841.

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 9 Jul 2025.

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