Head and Neck Squamous Cell CarcinomaPhase 2/3NimoBenSeqNCT07535567
Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma
A Phase 2/3 study testing Nimotuzumab, Nimotuzumab, Benmelstobart and Postoperative Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab, Nimotuzumab, Benmelstobart and Postoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 31 Dec 2028
- Phase
- Phase 2/3
- 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
- Age ≥ 18 years
- ECOG performance status: 0-2
- Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)
- Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively:
- ①pT3-4a;
- ②N2 disease (excluding cases with extranodal extension);
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- ③Closemargin < 5 mm;
- ④Lymphovascular and/or perineural invasion;
- ⑤Invasion depth > 5mm for T2 oral cavity cancer
- Laboratory tests must meet the following criteria:
- ①Hematologic parameters (within 14 days without transfusion or blood products): a. Hemoglobin (Hb) ≥80 g/L; b.Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; c. Platelet count (PLT) ≥ 80 × 10⁹/L;
- ②Biochemical parameters: a. Bilirubin (BIL) < 1.5 × upperlimit of normal (ULN); b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Expected survival time ≥ 6 months;
- Women of child bearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use reliable contraception during the study period; Male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose of study drug
- With PD-L1 immunohistochemistry testing
- Participant voluntarily agrees to participate in this study and signs the informed consent form
Who cannot join
- Pregnancy or lactation, or intention to become pregnant during the study period.
- Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.
- Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.
- Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.
- Diagnosis of another malignancy within 3 years prior to enrollment.
- History of Grade I or higher myocardial ischemia or myocardial infarction, severe arrhythmia, or ≥ Grade 2 congestive heart failure (New York Heart Association [NYHA] classification) within 6 months prior to enrollment.
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- Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment.
- Prior treatment of immunotherapy (including PD-1/PD-L1/CTLA-4 antibodies) or anti-EGFR agents.
- Known or suspected allergy to the investigational product or any drug related to this trial.
- Any other severe medical condition that, in the investigator's judgment, may compromise patient safety or interfere with the subject's ability to complete the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study
A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Nimotuzumab, Nimotuzumab, Benmelstobart, Postoperative Radiotherapy
- Keywords
- intermediate-risk pathological risk factor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
Nimotuzumab, BenmelstobartDrug
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.
Postoperative RadiotherapyRadiation
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)
| Study group | Role | What they receive |
|---|---|---|
| IMRT-Nimotuzumab + Benmelstobart | Experimental | Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy Receives: Drug: Nimotuzumab, Benmelstobart; Radiation: Postoperative Radiotherapy |
| IMRT-Nimotuzumab | Active comparator | Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT) Receives: Drug: Nimotuzumab; Radiation: Postoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS）
From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause
Measured: 3-year
Secondary outcomes (4)
Overall Survival (OS)
From enrollment until death from any cause
Measured: 3-year
Adverse Events (AEs)
From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).
Measured: 30 days after the last dose (approximately 8 weeks total).
Locoregional Recurrence-Free Survival (LRRFS)
Measured: From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
Distant Metastasis-Free Survival (DMFS)
Measured: From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535567
- Sponsor's protocol ID
- 2026HN02
- Acronym
- NimoBenSeq
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 30 Apr 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07535567
- Acronym / sponsor ID
- NimoBenSeq / 2026HN02
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- intermediate-risk pathological risk factor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Apr 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.
A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT-Nimotuzumab + Benmelstobart | Experimental | Drug: Nimotuzumab, Benmelstobart, Radiation: Postoperative RadiotherapyConcurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy |
| IMRT-Nimotuzumab | Active comparator | Drug: Nimotuzumab, Radiation: Postoperative RadiotherapyConcurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- ECOG performance status: 0-2
- Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)
- Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively:
- ①pT3-4a;
Key exclusion criteria (10 listed)
- Pregnancy or lactation, or intention to become pregnant during the study period.
- Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.
- Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.
- Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.
- Diagnosis of another malignancy within 3 years prior to 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 |
|---|---|---|
| NimotuzumabNimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. | Drug | IMRT-Nimotuzumab |
| Nimotuzumab, BenmelstobartNimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy. | Drug | IMRT-Nimotuzumab + Benmelstobart |
| Postoperative RadiotherapyIntensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions) | Radiation | IMRT-Nimotuzumab, IMRT-Nimotuzumab + Benmelstobart |
Primary outcome
Disease-Free Survival (DFS）
Time frame: 3-year
From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause
4 secondary outcomes
Overall Survival (OS)
Time frame: 3-year
Adverse Events (AEs)
Time frame: 30 days after the last dose (approximately 8 weeks total).
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
Distant Metastasis-Free Survival (DMFS)
Time frame: From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled
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 30 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nimotuzumab, Nimotuzumab, Benmelstobart and Postoperative Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 16 inclusion and 10 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 Guopei Zhu (86-23271699 ext. 5665, antica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS） (time frame: 3-year). 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 30 Apr 2026.