Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Radio-immunotherapy (Adebrelimab + RT)
- description
- Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) combined with radiotherapy (SBRT), followed by surgical resection.
- interventionNames
- Drug: Adebrelimab
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Immunotherapy Monotherapy (Adebrelimab)
- description
- Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) monotherapy, followed by surgical resection.
- interventionNames
- Drug: Adebrelimab
Primary outcomes (1)
- measure
- Major Pathological Response (MPR) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC). 2. Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer. 3. PD-L1 expression with a Combined Positive Score (CPS) ≥ 1. 4. Karnofsky Performance Status (KPS) score ≥ 70. 5. Age between 18 and 70 years (inclusive). 6. Evaluated by a multidisciplinary team (MDT) as resectable or borderline resectable, and suitable for preoperative Stereotactic Body Radiotherapy (SBRT). 7. Adequate organ function within 7 days prior to enrollment, meeting laboratory criteria for hematology, liver, and renal function. 8. 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). 9. Voluntary participation with a signed Informed Consent Form (ICF). Exclusion Criteria: 1. Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies. 2. Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections. 3. Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL). 4. Pregnant or breastfeeding women. 5. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.
References
Publications (0)
Data not yet available