Radiotherapy with nimotuzumab versus radiotherapy alone for platinum-ineligible advanced head and neck squamous cell carcinoma

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 open-label, randomized Phase III international multicenter trial randomized platinum-ineligible adults with stage III–IVB locoregionally advanced head and neck squamous cell carcinoma to receive definitive radiotherapy with or without nimotuzumab. Radiotherapy was delivered using intensity-modulated techniques (IMRT) and nimotuzumab was given in the experimental arm. Eligible patients were those unsuitable for surgery or cisplatin-based chemotherapy because of factors such as age, poor performance status, or renal dysfunction. The study compared efficacy and safety outcomes across roughly 70 participating centers, including Shandong First Medical University Affiliated Cancer Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eligible subjects must meet all of the following:

  * Age ≥18 years.
  * Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).
  * Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \[T3-4 N0-3 M0, or T1-2 N2-3 M0\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).
  * Suitable for definitive radiotherapy with curative intent.
  * At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:
* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;
* ECOG Performance Status \>2 (if this criterion is met, the ECOG criterion listed below may be waived);
* Renal dysfunction: creatinine clearance (CrCl) \<50 mL/min (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);
* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);
* Peripheral neuropathy \> Grade 1;
* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.

  * Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible (no need to retest if previously tested).
  * ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).
  * At least one measurable lesion per RECIST 1.1.
  * Expected survival ≥6 months.
  * Adequate hematologic function: WBC ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L.
  * Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault):
* Female CrCl = (140 - age) × weight (kg) × 0.85 / (72 × S\_cr \[mg/dL\])
* Male CrCl = (140 - age) × weight (kg) × 1.00 / (72 × S\_cr \[mg/dL\])

  * Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
  * Voluntary participation: signed written informed consent and ability to comply with visits and procedures.

Exclusion Criteria:

* Any of the following excludes enrollment:

  * Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.
  * Participation in another interventional clinical trial within 30 days prior to screening.
  * History of other malignancy (except cured basal cell carcinoma of the skin).
  * History of primary immunodeficiency.
  * Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).
  * Known HIV infection, or active viral hepatitis or active tuberculosis.
  * Major surgery within 90 days before first study treatment, or planned surgery during the study.
  * Known allergy to nimotuzumab or its excipients.
  * Deemed unsuitable to participate by the investigator.
  * Unwilling or unable to sign informed consent.
  * Receipt of a live vaccine within 30 days before first dose.

Where it's running

• Shandong First Medical University Affiliated Cancer Hospital
  Shandong, Province, China Recruiting

Study contacts

• Principal investigator: Man Hu — Shandong First Medical University Affiliated Cancer Hospital
• Study coordinator: Man Hu
• Email: hu5770@sina.com
• Phone: 86+15806698606

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nimotuzumab plus Immunotherapy and Chemotherapy before surgery for locally advanced head and neck cancer

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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.