Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC (NCT07554768) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC
China36 participantsStarted 2026-05-01
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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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).
Exclusion criteria
✕
What they're measuring
1
Major Pathological Response (MPR) Rate
Timeframe: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy).