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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two pre-surgery treatment approaches for patients with head and neck cancer that can be surgically removed. One group will receive low-dose radiation combined with targeted therapy and immunotherapy before surgery; the other group will receive targeted therapy and immunotherapy only. The goal is to see if adding a small dose of radiation helps shrink the tumor more before the operation. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with head and neck cancer (not nasopharyngeal carcinoma) that has been confirmed by biopsy - Your cancer has not spread to distant organs and is considered surgically removable - You are willing to undergo surgery after pre-treatment - You are in reasonably good physical condition (ECOG 0-1) - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - Your cancer is not surgically removable - You have significant organ dysfunction - You have previously received treatment for this cancer - You are not willing to have surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

200mg ivgtt q3w

DRUGAfatinib

Targeted therapy

RADIATIONLow dose radiotherapy

Radiotherapy


Locations(1)

Department of Radiation Oncology

Chengdu, Sichuan, China

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NCT07040956


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