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

Launched by WEST CHINA HOSPITAL · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with a type of head and neck cancer called squamous cell carcinoma that can be removed by surgery. The study will compare two treatment plans given before surgery: one combines a low dose of radiation with targeted therapy and immunotherapy, while the other uses targeted therapy and immunotherapy alone. The goal is to see if adding low-dose radiation helps improve treatment outcomes.

Adults aged 18 and older who have been newly diagnosed with this kind of cancer, which has not spread to other parts of the body, may be eligible. Participants must be healthy enough for surgery and have good overall health, including normal organ function. Those with certain other health problems, previous cancer treatments, or active infections may not qualify. If you take part, you will receive one of the two treatment plans before surgery and be closely monitored by the medical team. This study is not yet open for enrollment but aims to find better ways to treat operable head and neck cancer with fewer side effects.

Gender

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Eligibility criteria

• Inclusion Criteria:
• 1.Age 18 years or above. 2.Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition:
• • 1. Were newly diagnosed and without distant metastasis; were deemed surgically resectable, evaluated by a head and neck surgeon;
• • 2. Were willing to undergo surgery.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• 4. Adequate 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； ④INR≤ 1.5, APTT≤ 1.5×ULN; ⑤Written informed consent.
• Exclusion Criteria:
• • 1. 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.）
• • 2. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
• • 3. Any history of allergic disease, or a severe hypersensitivity reaction to drugs, or allergy to the study drug components.
• 4. Any of prior therapy with:
• • ①anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs； ②antitumor vaccine; ③any active vaccine against an infectious disease within 4 weeks before the first dose or planned during the study period; ④major surgery or serious trauma within 4 weeks before the first dose; ⑤toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria.
• • 5. 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.
• • 6. With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
• • 7. With hyperthyroidism, or organic thyroid disease.
• • 8. With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
• • 9. With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
• • 10. History of a clear neurological or psychiatric disorder.
• • 11. History of drug abuse or alcohol abuse.
• • 12. 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.
• • 13. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
• • 14. Any other factors that are not suitable for inclusion in this study judged by investigators.