Phase II Study of Neoadjuvant Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Neoadjuvant Immunochemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Single-Arm Prospective Clinical Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600123796

Enrollment

Unknown

Registered

2026-04-29

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Single arm:Neoadjuvant Immunochemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–70 years. 2. Histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma). 3. Stage III or IV without distant metastasis (per the 8th edition of the AJCC staging system). 4. Determined to be unresectable by multidisciplinary team (MDT) consensus, or suitable for organ function preservation therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 6. No severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, or renal impairment; no immunodeficiency. Laboratory parameters prior to enrollment must meet the following criteria: Hematology: White blood cell count >= 4 × 10?/L; absolute neutrophil count >= 1.5 × 10?/L; platelet count >= 100 × 10?/L; hemoglobin >= 90 g/L. Renal function: Serum creatinine = upper limit of normal (ULN) or creatinine clearance >= 60 mL/min. Hepatic function: Total serum bilirubin <= 1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.0 × ULN. Coagulation function: International normalized ratio (INR) <= 2.0; prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) within normal limits. 7. PD-L1 expression assessed by immunohistochemistry (IHC).

Exclusion criteria

Exclusion criteria: 1. Presence of severe comorbidities (e.g., liver cirrhosis, angina pectoris, or cardiomyopathy). 2. Uncontrolled infection, refractory epilepsy, and/or increased intracranial pressure, and/or uncontrolled hypertension, and/or uncontrolled hyperglycemia. 3. Documented human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV) infection (defined as positive HBsAg and detectable HBV-DNA). 4. History of other malignancies within the past 5 years that have not been effectively controlled, with the exception of cervical carcinoma in situ, cutaneous squamous cell carcinoma, or limited basal cell carcinoma of the skin. 5. Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Overall Survival;	—

Secondary

Measure	Time frame
Progression-Free Survival;Objective Response Rate;Disease Control Rate;Safety Endpoints;	—

Countries

China

Contacts

Public ContactYang Zhi

The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture

yangzhidoctor@163.com+86 743 866 9291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026