Recruiting

Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

What is being tested

SBRT+immunochemotherpy

+ Immunochemotherapy

+ cetuximab+immunochemotharpy

RadiationDrug

Who is being recruted

From 18 to 70 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: October 2023

See protocol details

Summary

Principal SponsorJiang Feng

Study ContactFeng Jiang, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial focuses on testing a new treatment approach for individuals with locally advanced head and neck squamous cell carcinoma (HNSCC). The study explores the combination of a type of precise radiation treatment called Stereotactic Body Radiotherapy (SBRT) with immunotherapy and chemotherapy. Immunotherapy involves using PD-1 antibodies, which help the immune system fight cancer cells, and cetuximab, a medication used in cancer treatment. The aim is to see if adding SBRT to the usual treatment can improve outcomes for patients before they undergo surgery. This approach could potentially enhance the effectiveness of current treatments and provide better options for patients with this type of cancer. Participants in this study will receive PD-1 antibodies and chemotherapy, with some also receiving SBRT targeted at the primary cancer site and any metastatic lymph nodes. After these treatments, participants will undergo surgery. The study will evaluate the effectiveness of the treatments by examining the cancer's response to the therapies, particularly looking at the changes in the cancer tissue after surgery. This will help determine if the combination of treatments leads to better results compared to standard therapies. The study aims to find out if the new approach can make tumors smaller and more manageable before surgery, potentially leading to better overall outcomes for patients.

Official TitleNeoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT06306846

Principal SponsorJiang Feng

Study ContactFeng Jiang, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection.

Immunohistochemical confirmed the HPV status through P16 immunostaining.

Male or female, Between the aged from 18 to 70 years,

Able to provide informed consent, comply with agreements, and sign research specific consent documents.

Show More Criteria

4 exclusion criteria prevent from participating

Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.

Patients who cannot accept radiotherapy in standard treatment.

Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids.

Autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as Guillain Barre syndrome), etc.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy every 3 weeks 2 cycles Step 2： SBRT with GTV expanded 3mm , 24Gy/3F, every other day within one week after the immunochemotherapy Step 3：Subsequent surgery and adjuvant treatments. Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses. Patients with pathological MPR/CR were treated with PD-1 antibody every two weeks up to 6 cycles after surgery with no adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

Group II

Active Comparator

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy every 3 weeks 2 cycles Step 2：Subsequent surgery and adjuvant treatments. Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses. Patients with pathological MPR/CR were treated with PD-1 antibody every two weeks up to 6 cycles after surgery without adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

Group III

Active Comparator

Step 1：neoadjuvant anti-PD-1 antibody and TP chemotherapy combined with cetuximab every 3 weeks for 2 cycles step2: Subsequent surgery and adjuvant treatments. Radical surgery will be performed within 4-6 weeks after the second cycle of immunochemotherapy，no matter the situation of the tumor regresses. Patients with pathological MPR/CR were treated with PD-1 antibody and cetuximab every two weeks up to 6 cycles after surgery without adjuvant chemoradiotherapy. Those not achieved MPR/CR will receive adjuvant radiotherapy or chemoradiotherapy according to NCCN guidelines.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhejiang Cancer Hospital

Hangzhou, ChinaOpen Zhejiang Cancer Hospital in Google Maps

Recruiting

One Study Center