Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07040956

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

Led by West China Hospital · Updated on 2026-05-04

98

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or above
  • Pathologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
  • Newly diagnosed without distant metastasis
  • Tumor deemed surgically resectable by a head and neck surgeon
  • Willingness to undergo surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function including neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10^9/L
  • Liver enzymes (ALT, AST, ALP) less than 2.5 times the upper limit of normal; total bilirubin ≤ 2 times upper limit of normal; albumin ≥ 2.8 g/dL
  • Creatinine clearance ≥ 60 ml/min
  • INR ≤ 1.5, APTT ≤ 1.5 times upper limit of normal
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • History of other malignancies except cured tumors without recurrence within 5 years (such as basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical cancer, gastrointestinal mucosal cancer)
  • Active autoimmune disease requiring systemic treatment or history of severe autoimmune disease
  • History of allergic disease, severe hypersensitivity, or allergy to study drug components
  • Prior therapy with anti-PD-1, anti-PD-L1/2, anti-CTLA-4, anti-EGFR antibodies, EGFR-TKIs, antitumor vaccines, or recent active vaccines within 4 weeks before first dose
  • Major surgery or serious trauma within 4 weeks before first dose
  • Unrecovered toxicity from prior antitumor therapy above grade 1 per CTCAE v5.0
  • Serious medical diseases including grade II or higher cardiac dysfunction, ischemic heart disease, arrhythmias, poorly controlled diabetes or hypertension, ejection fraction below 50%
  • Interstitial pneumonitis, non-infectious pneumonitis, active or uncontrolled pulmonary tuberculosis
  • Hyperthyroidism or organic thyroid disease
  • Active infection or unexplained fever during screening or within 48 hours before first dose
  • Active hepatitis B or C, positive HIV test, or AIDS
  • History of neurological or psychiatric disorders
  • History of drug or alcohol abuse
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study period without contraceptive measures
  • Use of investigational drugs within 4 weeks prior to first dose or concurrent enrollment in another trial
  • Other factors judged unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Radiation Oncology

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

X

Xingchen Peng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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