New hope for head and neck cancer patients who Can't take chemo
NCT ID NCT07445048
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests a new treatment for people with high-risk head and neck cancer who cannot receive the standard chemotherapy drug cisplatin. Participants receive radiation therapy combined with two drugs (nimotuzumab and benmelstobart) to see if this approach improves disease-free survival compared to standard care. The study enrolls 370 adults and follows them for up to 3 years after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 370 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 ≥ 18 years. 2. 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. 3. 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. 4. 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. 5. No evidence of distant metastasis on imaging. 6. 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). 7. Expected survival ≥ 6 months. 8. ECOG performance status 0-1. 9. Adequate hematologic function: WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L. 10. 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)) 11. Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN. 12. 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. 13. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures. exclusion Criteria: 1. Prior radiotherapy for head and neck cancer before enrollment. 2. Prior treatment with similar immunological or targeted agents. 3. Participation in another interventional clinical trial within 30 days prior to screening. 4. Evidence of distant metastasis. 5. 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. 6. Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.). 7. Known HIV infection, active viral hepatitis, or active tuberculosis. 8. Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study. 9. Hypersensitivity to any study drug or their components. 10. 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. 11. Subjects considered inappropriate for study participation by the investigator. 12. Subjects unwilling to participate in the study or unable to provide written informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shanghai 9th people's hospital
RECRUITINGShanghai, 200011, China
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Other studies related to the condition(s) this trial covers.
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