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Head and Neck Squamous Cell CarcinomaPhase 2NCT07906587

Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study

A Phase 2 study testing Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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
Search all trials

Trial summary

This is a prospective, single-arm, phase II study. It aims to evaluate whether neoadjuvant targeted therapy combined with immunotherapy and chemotherapy is effective and safe in patients with locally advanced, resectable head and neck squamous cell carcinoma (HNSCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
2 Sep 2026to Oct 2030
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.
  • Histologically or cytologically confirmed resectable stage III-IVB head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, or larynx according to the AJCC 9th edition.
  • For oropharyngeal cancer, tumor tissue must be available for HPV/P16 testing (testing is not required if previously performed).
  • Tumor tissue (from the primary tumor or resected tumor) must be available for EGFR and PD-L1 immunohistochemical testing (testing is not required if previously performed); genetic testing may be performed when necessary.
  • ECOG performance status 0-1.
  • At least one measurable lesion according to RECIST 1.1.
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  • Expected survival ≥6 months.
  • Adequate hematologic function: white blood cell count ≥3 × 10^9/L; absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; hemoglobin ≥90 g/L.
  • Adequate renal function: serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) >50 mL/min (using the Cockcroft-Gault formula):
  • Female CrCl = (140 - age) × body weight (kg) × 0.85 / (72 × Scr mg/dL); Male CrCl = (140 - age) × body weight (kg) × 1.00 / (72 × Scr mg/dL).
  • Adequate hepatic function: total serum bilirubin ≤1.5 × ULN; aspartate aminotransferase (AST) ≤2.5 × ULN; alanine aminotransferase (ALT) ≤2.5 × ULN.
  • Women of childbearing potential must have a negative pregnancy test within 2 weeks before the start of study treatment and must not be breastfeeding. -Female participants must agree to use effective contraception during the study and for 6 months after the last dose of study drug. Male participants must agree to use effective contraception during the study and for 6 months after the last dose of study drug.
  • Participants must voluntarily agree to participate, provide written informed consent, and be able to comply with the study visits and procedures specified in the protocol.

Who cannot join

  • Prior radiotherapy or chemotherapy; prior immunotherapy targeting PD-1/PD-L1; prior EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic therapy.
  • Treatment with systemic or local corticosteroids within 4 weeks before enrollment.
  • HIV-positive; HBsAg-positive with detectable HBV DNA (quantitative ≥1000 copies/mL); or positive blood screening for chronic hepatitis C (HCV antibody-positive) with detectable HCV RNA.
  • Participation in another interventional clinical trial within 30 days before screening.
  • History of other malignancies (except cured basal cell carcinoma of the skin). History of primary immunodeficiency.
  • Presence of poorly controlled concomitant diseases (e.g., heart failure, severe pulmonary disease, severe liver disease, psychiatric disorders, etc.).
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  • Major surgery within 90 days before the first dose of study drug or planned surgery.
  • Known allergy to any study drug or its components.
  • Pregnancy (confirmed by blood or urine HCG) or breastfeeding; or participants of childbearing potential (both male and female) who are unwilling or unable to use effective contraception until at least 6 months after the last study treatment.
  • Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.
  • Unwillingness to participate in the study or inability to sign informed consent.
  • Receipt of a live vaccine within 30 days before study drug administration.

Trial locations and contacts

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

Sheng Yang contact

86-316-5917421

medart@126.com

Sidan li contact

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences (CAMS), Langfang Campus

    Hebei, Hebei, 065001

    Sheng Yang, 86-316-5917421, medart@126.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Targeted Therapy Combined With Immunotherapy and Chemotherapy for Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study

This is a prospective, single-arm, phase II study. It aims to evaluate whether neoadjuvant targeted therapy combined with immunotherapy and chemotherapy is effective and safe in patients with locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).

Read the detailed description

This clinical trial adopts a prospective, single-arm, phase II trial design. Each neoadjuvant treatment cycle will be three weeks long. Patients will receive up to 3 cycles of neoadjuvant therapy, including nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin. After screening, eligible patients will be enrolled in the study. Patients will receive nimotuzumab weekly on days 1, 8, and 15; toripalimab on day 1; and chemotherapy with nab-paclitaxel and cisplatin on day 1 every 3 weeks for 3 cycles. Radical surgery will be performed approximately 1 month after the last neoadjuvant treatment. Postoperative adjuvant therapy will be selected by the investigator based on high-risk pathological factors. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include pathological complete response (pCR) rate, objective response rate (ORR), 2-year overall survival (OS) rate, 2-year event-free survival (EFS) rate, 2-year locoregional control (LRC) rate, quality of life, safety, and prognostic biomarkers. Short-term outcomes will be assessed according to RECIST 1.1, and adverse events will be evaluated using NCI-CTCAE 6.0. Approximately 86 patients aged 18-75 years with stage III-IVB resectable HNSCC will be enrolled. Enrollment is expected to be completed within 2 years, with at least 2 years of follow-up after the last patient is enrolled.

Being tested
Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatin
Keywords
Head and neck squamous cell carcinoma, Nimotuzumab
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.

  • Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatinDrug

    This study incorporates targeted therapy into the neoadjuvant treatment phase.

Study groups in NCT07906587
Study groupRoleWhat they receive
Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatinExperimentalNot described
Receives: Drug: Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatin

What is being measured

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

  1. MPR Major Pathological Response

    Proportion of patients with <10% viable tumor cells in the resected primary tumor and regional lymph nodes after neoadjuvant treatment.

    Measured: 3 months

Secondary outcomes (6)

  1. Pathological Complete Response (pCR) rate

    Proportion of patients with no residual viable tumor cells in the resected primary tumor and regional lymph nodes (ypT0N0).

    Measured: At the time of definitive surgery (postoperative pathological assessment), an expected average of 2.5 months after initiation of neoadjuvant therapy

  2. Objective Response Rate (ORR)

    Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1.

    Measured: After completion of 3 cycles of induction therapy (approximately 2.5 months after initiation of induction therapy)

  3. 2-year Event-Free Survival (EFS) rate

    Proportion of patients free from events (recurrence, distant metastasis, second primary cancer, or death from any cause) at 2 years.

    Measured: 2 years from treatment initiation

  4. 2-year Locoregional Control (LRC) rate

    Proportion of patients without locoregional recurrence at 2 years.

    Measured: 2 years from treatment initiation

  5. Safety and Tolerability

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE 6.0.

    Measured: From first dose to 30 days after last treatment

  6. Prognostic biomarkers

    Exploratory analysis of baseline EGFR and PD-L1 expression and their association with prognosis.

    Measured: Baseline (before initiation of treatment) and postoperative pathological assessment (approximately 3 months after initiation of treatment)

Timeline

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

  1. First posted30 Oct 2026
  2. Study start2 Sep 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2030 (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
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906587
Sponsor's protocol ID
NCCH0101
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
30 Oct 2026
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 Combining nimotuzumab and toripalimab with nab-paclitaxel plus cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 13 inclusion and 12 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 30 Oct 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?

Contact Sheng Yang (86-316-5917421, medart@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR Major Pathological Response (time frame: 3 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 NCT07906587.

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 30 Oct 2026.

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