OncoMatch/Clinical Trials/NCT07007364
Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
Is NCT07007364 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab Combined With Albumin Paclitaxel for early-stage oral squamous cell carcinoma.
Treatment: Adebrelimab Combined With Albumin Paclitaxel — This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma. Eligible patients received neoadjuvant low-dose radiotherapy combined with adibelizumab and monotherapy with albumin paclitaxel for two cycles. Radical surgical resection is planned to be carried out 3 to 4 weeks after neoadjuvant therapy. Patients who obtain PCR after evaluation by the researchers after the operation will be maintained for 6 cycles of immunomonotherapy. The primary endpoints were the rate of pathological response and the rate of exemption from cervical lymph node dissection. The secondary endpoints included progression-free survival, local control rate, distant metastasis-free rate, overall survival, safety and quality of life of patients, as well as the exploration of biomarkers
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage I, II
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: taxane
Patients who have previously received treatment with taxanes
Cannot have received: anti-tumor treatment
Exception: within 2 weeks before the first use of the study drug
Have received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 2 weeks before the first use of the study drug
Cannot have received: investigational drug
Exception: within 4 weeks before the first use of the investigational drug or no more than 5 half-lives from the last investigational drug use
Having received any other investigational drugs within 4 weeks before the first use of the investigational drug or no more than 5 half-lives from the last investigational drug use
Cannot have received: anti-tumor vaccine
Exception: within 4 weeks before the first administration of the study drug
Those who have received anti-tumor vaccines or those who have received live vaccines within 4 weeks before the first administration of the study drug
Cannot have received: major surgery
Exception: within 4 weeks before the first use of the study drug
Underwent major surgery or suffered severe trauma within 4 weeks before the first use of the study drug
Lab requirements
Blood counts
WBC ≥3.5×10^9/L, neutrophil count ≥2.0×10^9/L, hemoglobin ≥100g/L, platelet count ≥100×10^9/L
Kidney function
Creatinine clearance rate ≥60 mL/min
Liver function
Total bilirubin ≤1.5x ULN; AST/ALT ≤2.5x ULN; alkaline phosphatase ≤2.5x ULN
Cardiac function
Normal myocardial enzymes, electrocardiogram and echocardiography
Vital organs function normally and can tolerate the prescribed treatment plan: bone marrow hematopoietic function, liver and kidney functions, thyroid function, coagulation function, pituitary function, inflammatory infection indicators, myocardial enzymes, electrocardiogram and echocardiography are normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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