New combo therapy offers hope for head and neck cancer patients who can't have chemo
NCT ID NCT07333274
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the targeted drug nimotuzumab to standard radiation therapy helps control advanced head and neck cancer better than radiation alone. It is for 335 adults whose cancer has spread locally but who cannot take platinum-based chemotherapy. The main goal is to see if the combination keeps the cancer from growing or coming back for longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 335 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong First Medical University Affiliated Cancer Hospital
RECRUITINGShandong, Province, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radiation plus targeted antibody tested in older head and neck cancer patients
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a new drug shrink tumors that resist standard care?
- Cutting radiation after surgery: a new hope for head and neck cancer patients?
- Can a new drug combo revive Immunotherapy's power against resistant tumors?
- Can an immunotherapy combo shrink throat tumors before surgery?