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Radiation plus targeted antibody tested in older head and neck cancer patients

NCT ID NCT07821242

Disease control Sponsor: Ke Hu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether adding nimotuzumab to intensity-modulated radiation therapy helps older adults with locally advanced head and neck squamous cell carcinoma who cannot tolerate standard chemotherapy. The study enrolls patients aged 65 and older with EGFR-positive tumors. Everyone receives weekly nimotuzumab infusions plus daily radiation. The main goal is to see how many patients are alive one year later, with secondary measures tracking tumor response, progression, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nimotuzumab, an antibody given by intravenous infusion that targets the EGFR protein on tumor cells
What this could lead to
If it works, this could offer older adults with head and neck cancer a radiation-based option that avoids the harsh side effects of standard chemotherapy.
What could go wrong
This is a small, single-arm phase II study with no comparison group, so any benefit seen could be due to radiation alone or patient selection. Nimotuzumab can cause infusion reactions, skin rash, and other side effects, and the trial may not show a survival advantage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures. Exclusion Criteria: 1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head & neck cancer Radiotherapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking Union Medical College Hospital

    Beijing, China

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