Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, phase II trial enrolling adults with stage III-IVB locally advanced, resectable head and neck squamous cell carcinoma. Patients receive up to three 21-day neoadjuvant cycles of nimotuzumab weekly, toripalimab once every cycle, and nab-paclitaxel plus cisplatin every 3 weeks, followed by radical surgery about one month after the last treatment. Primary outcome is major pathological response; secondary outcomes include complete response, objective response rate, 2-year survival metrics, locoregional control, quality of life, safety, and biomarker analysis. Treatments are stopped or adjusted per safety and clinical criteria, and adjuvant therapy is chosen by the investigator based on pathology. Approximately 86 eligible patients aged 18–75 are planned to be enrolled with two years of accrual and at least two years of follow-up after the last patient enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.).
* 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.

Where it's running

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

Study contacts

• Study coordinator: Sheng Yang
• Email: medart@126.com
• Phone: 86-316-5917421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.