Status:
RECRUITING
A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.
Lead Sponsor:
West China Hospital
Conditions:
Head and Neck Squamous Cell Carcinoma
Low-dose Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 resectab...
Detailed Description
Head and neck squamous cell carcinoma (HNSCC) is a common malignant tumor in the world. Due to its special anatomical location, HNSCC affects patients' appearance and physiological functions. Comprehe...
Eligibility Criteria
Inclusion Criteria:
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Age 18 years or above.
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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.
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Written informed consent.
Exclusion Criteria:
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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.)
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Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
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Any history of allergic disease, or a severe hypersensitivity reaction to drugs, or allergy to the study drug components.
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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.
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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.
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With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
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With hyperthyroidism, or organic thyroid disease.
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With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
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With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
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History of a clear neurological or psychiatric disorder.
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History of drug abuse or alcohol abuse.
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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.
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Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
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Any other factors that are not suitable for inclusion in this study judged by investigators.
Key Trial Info
Start Date :
June 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT07040956
Start Date
June 28 2025
End Date
July 1 2026
Last Update
December 29 2025
Active Locations (1)
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1
Department of Radiation Oncology
Chengdu, Sichuan, China, 610000