BridgeMD
Compares treatment options for Head & Neck Squamous Cell Carcinoma
Official title Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07333274
What this study is testing
What is Nimotuzumab?
Nimotuzumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head & neck squamous cell carcinoma.
Also referred to as Nimotuzumab injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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),
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible people 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...
- 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...
- Suitable for definitive radiotherapy with curative intent.
You likely can't join if
- 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 treatment 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).
See the full eligibility criteria
- Eligible people 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shandong, Province, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shandong, Province, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.