NCT07333274 Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT07333274 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | Head & Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 335 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2028-01-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 335 participants in total. It began in 2026-01-05 with a primary completion date of 2028-01-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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),
Eligibility Criteria
Inclusion Criteria: * 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: * 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. Exclusion Criteria: * 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). * 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.
Contact & Investigator
Man Hu
PRINCIPAL INVESTIGATOR
Shandong First Medical University Affiliated Cancer Hospital
Frequently Asked Questions
Who can join the NCT07333274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head & Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07333274 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 335 participants.
Is NCT07333274 currently recruiting?
Yes, NCT07333274 is actively recruiting participants. Contact the research team at hu5770@sina.com for enrollment information.
Where is the NCT07333274 trial being conducted?
This trial is being conducted at Shandong, China.
Who is sponsoring the NCT07333274 clinical trial?
NCT07333274 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is Man Hu at Shandong First Medical University Affiliated Cancer Hospital. The trial plans to enroll 335 participants.