Adbelimab combined with nimotuzumab (chemotherapy-free) as neoadjuvant therapy for resectable locally advanced squamous cell carcinoma of the head and neck: A single-center, single-arm, open-label, Phase II clinical trial

Adbelimab combined with nimotuzumab as neoadjuvant therapy for resectable locally advanced squamous cell carcinoma of the head and neck: A single-center, single-arm, open-label, Phase II clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122175

Enrollment

Unknown

Registered

2026-04-09

Start date

2026-04-09

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

test group:Neoadjuvant therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years. 2. Pathologically confirmed, resectable Stage III-IVA locally advanced head and neck squamous cell carcinoma (LA-HNSCC), with primary sites including the oral cavity, oropharynx, hypopharynx, or larynx. For oropharyngeal cancer, positive P16 expression is required. 3. Positive EGFR expression (Immunohistochemistry (IHC) >=1+); PD-L1 Combined Positive Score (CPS) >=1 as determined by the 22C3 pharmDx assay. 4. Organ function adequate for surgery. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 is required for all patients. 5. Normal organ function. 6. Patients must provide pre-treatment tumor tissue or blood samples during the study period. 7. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of distant metastatic disease (M1) or unresectable lesions. Patients must have radiologically measurable lesions. 2. Previous treatment with anti-PD-1/PD-L1 agents or anti-EGFR therapy. 3. Active autoimmune disease or immunodeficiency. 4. Inadequate cardiac, pulmonary, or other organ function, hematopoietic dysfunction, or other physical conditions that would preclude the completion of treatment, or patient refusal of neoadjuvant therapy. 5. Pregnancy or lactation. 6. Requirement for immunosuppressive medication, or chronic active infection (e.g., Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)). 7. History of allogeneic bone marrow transplantation or solid organ transplantation.

Design outcomes

Primary

Measure	Time frame
Major Pathological Response Rate;	—

Secondary

Measure	Time frame
Event-Free Survival;Overall Survival;Pathological Complete Response Rate;Objective Response Rate;Incidence of Treatment-Related Adverse Events;	—

Countries

China

Contacts

Public ContactWenbin Lei

The First Affiliated Hospital,Sun Yat-sen University

leiwb@mail.sysu.edu.cn+86 13922113299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026