Head & Neck Squamous Cell CarcinomaPhase 3NCT07333274
Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Nimotuzumab and intensity-modulated technique（IMRT） in people with Head & Neck Squamous Cell Carcinoma and Head & Neck Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC), Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Squamous Cell Carcinoma, Head & Neck Cancer
- What is being tested?
- Nimotuzumab and intensity-modulated technique（IMRT）
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 5 Jan 2030
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
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, 1 recruiting
- Recruiting
Shandong First Medical University Affiliated Cancer Hospital
Shandong, Province
Man Hu, 86+15806698606 ext. （0531）67626151, hu5770@sina.com
About this study
Official title: An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),
Read the detailed description
This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC), The study aims to evaluate the efficacy and safety of radiotherapy combined with nimotuzumab in platinum-ineligible patients with (LA-HNSCC).Around 70 study sites were involved in the trial.
- Being tested
- Nimotuzumab, intensity-modulated technique（IMRT）
- Keywords
- Nimotuzumab, Radiotherapy, locoregionally advanced head and neck squamous cell carcinoma, LA-HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called Nimotuzumab injection
Treatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).
intensity-modulated technique（IMRT）Radiation
Also called photon IMRT, proton IMPT, intensity-modulated technique
Treatment regimen： Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy plus nimotuzumab | Experimental | radiotherapy plus nimotuzumab Receives: Drug: Nimotuzumab; Radiation: intensity-modulated technique（IMRT） |
| Radiotherapy alone in LA-HNSCC | Active comparator | Not described Receives: Radiation: intensity-modulated technique（IMRT） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
the proportion of patients in a clinical study who remain free of disease progression (including local recurrence, regional lymph node metastasis, distant metastasis, or second primary malignancy) and have not died from any cause within 2 years from the start of treatment (or randomization in randomized controlled trials).
Measured: 24 months after treatment initiation
Secondary outcomes (5)
2-year locoregional control (LRC) rate.
the proportion of patients in a clinical study who remain free of disease progression within 2 years from the start of treatment (or randomization in randomized controlled trials).
Measured: 24 months after treatment initiation
2-year distant metastasis rate.
the prproportion of participants with distant metastatic progression within 24 months,
Measured: 24 months after treatment initiation
Overall Survival (OS)
the prproportion of participants surviving at 2 years after enrolling,regardless of disease status.
Measured: 24 months after treatment initiation
Objective Response Rate (ORR; CR+PR by RECIST 1.1).
the proportion of patients with measurable malignant tumors who achieve a complete response (CR) or partial response (PR)
Measured: 24 months after treatment initiation
Quality of Life (QoL)
Measured: 24 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck Squamous Cell CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Hu, Shandong Cancer Hospital and Institute
- Investigators
- Man Hu, Principal investigator, Shandong First Medical University Affiliated Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333274
- Sponsor's protocol ID
- IST-Nim-HNSCC-45
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
- ClinicalTrials.gov ID
- NCT07333274
- Acronym / sponsor ID
- IST-Nim-HNSCC-45
- Keywords
- Nimotuzumab, Radiotherapy, locoregionally advanced head and neck squamous cell carcinoma, LA-HNSCC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 5 Jan 2030 (estimated)
- First posted
- 12 Jan 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 an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),
Detailed description
This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC), The study aims to evaluate the efficacy and safety of radiotherapy combined with nimotuzumab in platinum-ineligible patients with (LA-HNSCC).Around 70 study sites were involved in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy plus nimotuzumab | Experimental | Drug: Nimotuzumab, Radiation: intensity-modulated technique（IMRT）radiotherapy plus nimotuzumab |
| Radiotherapy alone in LA-HNSCC | Active comparator | Radiation: intensity-modulated technique（IMRT） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Eligible subjects must meet all of the following:
- 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);
Key exclusion criteria (12 listed)
- Any of the following excludes enrollment:
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 |
|---|---|---|
| NimotuzumabAlso: Nimotuzumab injectionTreatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy). | Drug | Radiotherapy plus nimotuzumab |
| intensity-modulated technique（IMRT）Also: photon IMRT, proton IMPT, intensity-modulated techniqueTreatment regimen： Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week. | Radiation | Radiotherapy alone in LA-HNSCC, Radiotherapy plus nimotuzumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 24 months after treatment initiation
the proportion of patients in a clinical study who remain free of disease progression (including local recurrence, regional lymph node metastasis, distant metastasis, or second primary malignancy) and have not died from any cause within 2 years from the start of treatment (or randomization in randomized controlled trials).
5 secondary outcomes
2-year locoregional control (LRC) rate.
Time frame: 24 months after treatment initiation
2-year distant metastasis rate.
Time frame: 24 months after treatment initiation
Overall Survival (OS)
Time frame: 24 months after treatment initiation
Objective Response Rate (ORR; CR+PR by RECIST 1.1).
Time frame: 24 months after treatment initiation
Quality of Life (QoL)
Time frame: 24 months after treatment initiation
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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Head & Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
Man Hu principal investigator
Shandong First Medical University Affiliated Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab and intensity-modulated technique（IMRT） in people with Head & Neck Squamous Cell Carcinoma and Head & Neck Cancer, run by Shandong Cancer Hospital and Institute 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 22 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: looking for participants now, as of the sponsor's last update on 12 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Man Hu (86+15806698606 ext. （0531）67626151, hu5770@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 24 months after treatment initiation). 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 12 Jan 2026.