NCT07554768Not yet recruitingPhase 2
Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC
A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- Chen Chunyan
- Diseases
- Head and neck cancer
- NCT number
- NCT07554768
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 1 May 2026 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.
Other illness
- 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).
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.