RecruitingPhase 2NCT07040956

A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.

A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.

Sponsor

West China Hospital

Enrollment

98 participants

Start Date

Jun 28, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Targeted Therapy Immunotherapy Low Dose Radiotherapy

Summary

This study aimed to compare the efficacy of neoadjuvant low-dose radiotherapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone in patients with resectable head and neck squamous cell carcinoma.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Age 18 years or above.
Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition:
①Were newly diagnosed and without distant metastasis; were deemed surgically resectable, evaluated by a head and neck surgeon;
②Were willing to undergo surgery;
③Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
④Adequate organ and bone marrow function: Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L; ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL；Creatinine clearance ≥ 60 ml/min；INR≤ 1.5, APTT≤ 1.5×ULN.
Written informed consent.

Exclusion Criteria14

History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
Any history of allergic disease, or a severe hypersensitivity reaction to drugs, or allergy to the study drug components.
Any of prior therapy with:
With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
With hyperthyroidism, or organic thyroid disease.
With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
History of a clear neurological or psychiatric disorder.
History of drug abuse or alcohol abuse.
Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
Any other factors that are not suitable for inclusion in this study judged by investigators.