Postoperative radiotherapy with nimotuzumab followed by bemcentinib for high-risk head and neck cancer patients who can't take cisplatin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, controlled, open-label Phase III trial enrolling 370 patients randomized 1:1 to receive postoperative radiotherapy combined with nimotuzumab followed by bemcentinib or to a control group. Eligible patients are adults with histologically confirmed locally advanced (AJCC 8th ed. stage III-IVB) head and neck squamous cell carcinoma who underwent radical surgery and have at least one high-risk pathologic feature and are ineligible for cisplatin. The primary endpoint is disease-free survival (DFS) with planned enrollment completed in about 2 years and a 3-year follow-up after the last patient is enrolled. Safety and secondary outcomes will be monitored during and after treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai 9th people's hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Guopei Zhu
• Email: antica@gmail.com
• Phone: 23211699-5665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.