Head & Neck Squamous Cell CarcinomaPhase 3NCT07445048
Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Bemcentinib, Nimotuzumab and radiotherapy in people with Head & Neck Squamous Cell Carcinoma and Head & Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. 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, Postoperative Adjuvant Treatment
- What is being tested?
- Bemcentinib, Nimotuzumab and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2026to 5 Mar 2031
- 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
- Age ≥ 18 years.
- Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age > 70 years;② Renal insufficiency (creatinine clearance < 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy > Grade 1;⑥ Patient refusal of chemotherapy.
- Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
- Underwent radical surgery with at least one high-risk feature:
- Extracapsular extension (ECE) of lymph node metastasis; Close margin (< 1 mm) or positive margin;
- 4 metastatic lymph nodes, or multiple perineural invasions.
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- No evidence of distant metastasis on imaging.
- Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV/p16 testing is required (testing may be waived if results are already available).
- Expected survival ≥ 6 months.
- ECOG performance status 0-1.
- Adequate hematologic function:
- WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) > 50 mL/min (calculated by Cockcroft-Gault formula):
- Female: CrCl = (140 - Age) × Weight (kg) × 0.85 / (72 × Scr (mg/dL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 / (72 × Scr (mg/dL))
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN.
- Women of childbearing potential: negative serum or urine pregnancy test within 14 days before enrollment, and agreement to use effective contraception during the study.Male subjects: use effective contraception from the start of treatment until 180 days after the last study drug administration.
- Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.
Who cannot join
- Prior radiotherapy for head and neck cancer before enrollment.
- Prior treatment with similar immunological or targeted agents.
- Participation in another interventional clinical trial within 30 days prior to screening.
- Evidence of distant metastasis.
- History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary / follicular), localized prostate cancer, and ductal carcinoma in situ.
- Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.).
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- Known HIV infection, active viral hepatitis, or active tuberculosis.
- Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study.
- Hypersensitivity to any study drug or their components.
- Pregnancy (confirmed by serum or urine HCG test) or lactating women; subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment.
- Subjects considered inappropriate for study participation by the investigator.
- Subjects unwilling to participate in the study or unable to provide written informed consent.
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
Shanghai 9th people's hospital
Shanghai, 200011
Shengjin Dou, 86-021-23271699-5665, doushengjin@126.com
About this study
Official title: A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.
The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
- Being tested
- Bemcentinib, Nimotuzumab, radiotherapy
- 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.
BemcentinibDrug
1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy.
NimotuzumabDrug
Also called Nimotuzumab injection
200 mg on Day 1, once weekly (QW) for a total of 7 cycles.
radiotherapyRadiation
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Drug: Bemcentinib; Drug: Nimotuzumab; Radiation: radiotherapy |
| Control Group | Active comparator | Not described Receives: Drug: Nimotuzumab; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS
Measured: From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled
Secondary outcomes (6)
Overall Survival (OS)
Measured: From enrollment until death from any cause, assessed up to 3 years after last patient enrolled
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
Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 (V3) questionnaires.The EORTC QLQ-C30 is a 30-item validated questionnaire designed to assess the quality of life in cancer patients. It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea/vomiting), a global health status/quality of life scale, and six single items assessing additional symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single items are scored on a range from 0 to 100. For the functional scales and global health status scale, higher scores indicate better quality of life or functioning. For the symptom scales and single items, higher scores indicate worse symptoms or greater severity.
Measured: Up to 24 months.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (CTCAE 5.0）
Measured: From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).]
Change From Baseline in Head and Neck-Specific Quality of Life Score (EORTC QLQ-H&N35)
Assessed using EORTC QLQ-H\&N35 questionnaires.The EORTC QLQ-H\&N35 is a 35-item validated questionnaire specifically designed to assess quality of life in head and neck cancer patients. It includes seven symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single items addressing additional head and neck-specific symptoms (e.g., teeth problems, mouth opening, dry mouth, sticky saliva, coughing, feeling ill, use of painkillers, nutritional supplements, feeding tube, weight loss, and weight gain). All scales and single items are scored on a range from 0 to 100, with higher scores indicating worse symptoms or greater severity.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start4 Mar 2026
- Primary completion5 Mar 2028 (estimated)
- Study completion5 Mar 2031 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 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
- NCT07445048
- Sponsor's protocol ID
- BPL-Nim-SCCHN-91
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy
- ClinicalTrials.gov ID
- NCT07445048
- Acronym / sponsor ID
- BPL-Nim-SCCHN-91
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 5 Mar 2031 (estimated)
- First posted
- 3 Mar 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 III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.
The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Bemcentinib, Drug: Nimotuzumab, Radiation: radiotherapy |
| Control Group | Active comparator | Drug: Nimotuzumab, Radiation: radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years.
- Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age > 70 years;② Renal insufficiency (creatinine clearance < 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy > Grade 1;⑥ Patient refusal of chemotherapy.
- Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
- Underwent radical surgery with at least one high-risk feature:
- Extracapsular extension (ECE) of lymph node metastasis; Close margin (< 1 mm) or positive margin;
Key exclusion criteria (12 listed)
- Prior radiotherapy for head and neck cancer before enrollment.
- Prior treatment with similar immunological or targeted agents.
- Participation in another interventional clinical trial within 30 days prior to screening.
- Evidence of distant metastasis.
- History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary / follicular), localized prostate cancer, and ductal carcinoma in situ.
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 |
|---|---|---|
| Bemcentinib1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy. | Drug | Study Group |
| NimotuzumabAlso: Nimotuzumab injection200 mg on Day 1, once weekly (QW) for a total of 7 cycles. | Drug | Control Group, Study Group |
| radiotherapyIntensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion. | Radiation | Control Group, Study Group |
Primary outcome
Disease-Free Survival (DFS
Time frame: From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled
6 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment until death from any cause, assessed up to 3 years after last patient enrolled
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
Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)
Time frame: Up to 24 months.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).]
Change From Baseline in Head and Neck-Specific Quality of Life Score (EORTC QLQ-H&N35)
Time frame: Up to 24 months
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 17 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.
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 Bemcentinib, Nimotuzumab and radiotherapy in people with Head & Neck Squamous Cell Carcinoma and Head & Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 18 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 17 Apr 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 Guopei Zhu (23211699-5665, 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: From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled). 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 17 Apr 2026.