Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC

Starting soon · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma

In brief

The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).

Key facts

Study ID

NCT07554768

Run by

Chen Chunyan

People needed

36

Starts

2026-05-01

Expected to finish

2029-05-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC).
• Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer.
• PD-L1 expression with a Combined Positive Score (CPS) ≥ 1.
• Karnofsky Performance Status (KPS) score ≥ 70.
• Age between 18 and 70 years (inclusive).
• Evaluated by a multidisciplinary team (MDT) as resectable or borderline resectable, and suitable for preoperative Stereotactic Body Radiotherapy (SBRT).
• Adequate organ function within 7 days prior to enrollment, meeting laboratory criteria for hematology, liver, and renal function.
• Anatomical requirements for SBRT: Lesions must be localized with adequate anatomical space for high-precision radiotherapy without exceeding safety limits for Organs at Risk (OARs).
• Voluntary participation with a signed Informed Consent Form (ICF).

You may not qualify if…

• Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.
• Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections.
• Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL).
• Pregnant or breastfeeding women.
• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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