Head & Neck CancerPhase 2NCRHNCNCT07821242
Nimotuzumab Plus Radiotherapy in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Nimotuzumab in people with Head & Neck Cancer and Radiotherapy, run by Ke Hu at 1 site in China.
Trial summary
This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Head & Neck Cancer, Radiotherapy
- What is being tested?
- Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 23 Mar 2029
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years old.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- Positive EGFR test result in tumor tissue.
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- ECOG performance status 0-2 OR KPS score ≥ 60.
- Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
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- At least one measurable lesion according to RECIST version 1.1.
- Estimated life expectancy ≥ 6 months.
- 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.
- Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) >60 mL/min calculated by Cockcroft-Gault formula.
- Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
- Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Who cannot join
- Age ≥ 65 years old.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- Positive EGFR test result in tumor tissue.
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- ECOG performance status 0-2 OR KPS score ≥ 60.
- Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
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- At least one measurable lesion according to RECIST version 1.1.
- Estimated life expectancy ≥ 6 months.
- 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.
- Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) >60 mL/min calculated by Cockcroft-Gault formula.
- Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
- Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing
Ke Hu, 010-69154011, huk@pumch.cn
About this study
Official title: A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined With Radiotherapy for Elderly Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.
- Conditions
- Head & Neck Cancer, Radiotherapy
- Being tested
- Nimotuzumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Humanized anti-EGFR monoclonal antibody, administered by intravenous infusion once weekly during the whole radiotherapy period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nimotuzumab Combined with Radiotherapy | Experimental | Patients with locally advanced unresectable head-and-neck squamous cell carcinoma receive definitive intensity-modulated radiotherapy (IMRT) to the primary tumor and regional lymph nodes, concurrently with weekly intravenous nimotuzumab during the radiotherapy course. Tumor response is assessed by RECIST 1.1 and adverse events are graded by CTCAE v5.0. Receives: Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis.
Measured: At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal
Secondary outcomes (3)
2-year progression-free survival rate
Progression-free survival (PFS) is defined as the time from initiation of study treatment to documented disease progression (locoregional recurrence or distant metastasis) or death from any cause, whichever occurs first. The 2-year PFS rate is estimated by the Kaplan-Meier method. Imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3-months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up.
Measured: From start of study treatment up to 24 months
2-year locoregional control rate
Locoregional control (LRC) is defined as the time from the start of study treatment until clinical or imaging-confirmed locoregional tumor recurrence (primary site or regional lymph nodes). Distant metastasis alone is not regarded as a locoregional control event. The 2-year locoregional control rate will be estimated using the Kaplan-Meier method. Tumor imaging assessments are performed at 4 weeks and 12 weeks after radiotherapy completion, then every 3 months until disease progression, subject intolerance, withdrawal, or completion of 2-year follow-up.
Measured: From start of study treatment through 2-year follow-up
Overall survival
Overall survival (OS) is defined as the time from initiation of study treatment to death from any cause. Patients who are alive will be censored at the end of 2-year follow-up. Survival status will be collected during regular follow-up visits.
Measured: From start of study treatment through 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ke Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ke Hu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821242
- Sponsor's protocol ID
- K9728
- Other IDs
- I-26PJ0638
- Acronym
- NCRHNC
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined With Radiotherapy for Elderly Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT07821242
- Acronym / sponsor ID
- NCRHNC / K9728
- Conditions
- Head & Neck Cancer, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ke HuUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Mar 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nimotuzumab Combined with Radiotherapy | Experimental | Drug: NimotuzumabPatients with locally advanced unresectable head-and-neck squamous cell carcinoma receive definitive intensity-modulated radiotherapy (IMRT) to the primary tumor and regional lymph nodes, concurrently with weekly intravenous nimotuzumab during the radiotherapy course. Tumor response is assessed by RECIST 1.1 and adverse events are graded by CTCAE v5.0. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Age ≥ 65 years old.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- Positive EGFR test result in tumor tissue.
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- ECOG performance status 0-2 OR KPS score ≥ 60.
Key exclusion criteria (12 listed)
- Age ≥ 65 years old.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- Positive EGFR test result in tumor tissue.
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- ECOG performance status 0-2 OR KPS score ≥ 60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimotuzumabHumanized anti-EGFR monoclonal antibody, administered by intravenous infusion once weekly during the whole radiotherapy period. | Drug | Experimental: Nimotuzumab Combined with Radiotherapy |
Primary outcome
Objective response rate
Time frame: At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal
Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis.
3 secondary outcomes
2-year progression-free survival rate
Time frame: From start of study treatment up to 24 months
2-year locoregional control rate
Time frame: From start of study treatment through 2-year follow-up
Overall survival
Time frame: From start of study treatment through 2-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab in people with Head & Neck Cancer and Radiotherapy, run by Ke Hu 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 12 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: opening soon, as of the sponsor's last update on 15 Sep 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 Ke Hu (010-69154011, huk@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.