Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adebrelimab, radiotherapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Overview
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).
Detailed description
This is a randomized, controlled, open-label, Phase II clinical trial designed to compare the efficacy and safety of neoadjuvant radiotherapy combined with Adebrelimab versus Adebrelimab monotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Experimental Arm (Radio-immunotherapy): Patients will receive neoadjuvant radiotherapy (SBRT 24 Gy in 3 fractions) followed by or concurrent with 2 cycles of Adebrelimab (1200mg, Q3W).
Control Arm (Immunotherapy alone): Patients will receive 2 cycles of Adebrelimab (1200mg, Q3W) as monotherapy.
Following the completion of neoadjuvant therapy, a multidisciplinary team (MDT) will evaluate the patients' response. Eligible patients will then undergo standard surgical resection of the primary tumor and neck dissection within 3 to 4 weeks after the last dose of immunotherapy.
The primary endpoint is the Major Pathological Response (MPR) rate, defined as less than or equal to 10% residual viable tumor in the resected specimen. Secondary endpoints include Pathological Complete Response (pCR) rate, Objective Response Rate (ORR) according to RECIST 1.1, Event-Free Survival (EFS), and the incidence of treatment-emergent adverse events (TEAEs) graded by CTCAE 5.0.
Interventions
- Drug Adebrelimab
A humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting. - Radiation radiotherapy
Neoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of \[24\] Gy in \[3\] fractions).
Primary outcome measures
- Major Pathological Response (MPR) Rate [Time frame: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy).]
Secondary outcome measures (3)
- Pathological Complete Response (pCR) Rate [Time frame: At the time of surgery.]
- Objective Response Rate (ORR) [Time frame: From the first dose of neoadjuvant therapy until pre-operative clinical evaluation (approximately 6 weeks).]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From the start of treatment up to 30 days after surgery.]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07554768 · B2026-158-01