- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06306846
Neoadjuvant SBRT in Localized Advanced HNSCC
Neoadjuvant Stereotactic Body Radiotherapy(SBRT)Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Feng Jiang, MD
- Phone Number: 0086-571-88128202
- Email: jiangfeng@zjcc.org.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Feng Jiang, MD
- Phone Number: 0086-571-88128202
- Email: jiangfeng@zjcc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- ZPS is less than 2.
- Adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by Researchers, able to tolerate neoadjuvant anti-PD-1, anti-EGFR, and radiation therapy.
- Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe.
Exclusion Criteria:
- 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
SBRT radiotherapy,followed with PD-1 monoclonal antibody and TP chemotherapy
Other Names:
|
Active Comparator: control
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. |
PD-1 monoclonal antibody and TP chemotheapy
|
Active Comparator: Cetuximab+immunochemo
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. |
PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
major pathology response (MPR)
Time Frame: 4-6 weeks after the end of the neoadjuvant therapy
|
major pathology response
|
4-6 weeks after the end of the neoadjuvant therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: feng Jiang, MD, Zhejiang Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11235794
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Squamous Carcinoma
-
Washington University School of MedicineMerck Sharp & Dohme LLCActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Carcinoma, Squamous Cell of Head and Neck | Neoplasms, Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
-
Bristol-Myers SquibbActive, not recruitingSquamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and NeckFrance
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Advanced Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell Carcinoma | Locally Advanced Head and Neck Squamous Cell Carcinoma | Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage IV Cutaneous...United States
-
Chase Heaton, MDIncyte Corporation; OncoSec Medical IncorporatedTerminatedRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma | Unresectable Head and Neck Squamous Cell CarcinomaUnited States
-
Xiang LuRecruitingHead and Neck Squamous Cell Carcinomas | Resectable Head and Neck Squamous-cell CarcinomaChina
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingHead and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell CarcinomaUnited States
-
Washington University School of MedicineActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
-
Eben RosenthalNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | HNSCC | Head Cancer Neck
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
Clinical Trials on SBRT+immunochemotherpy
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedLung CancerUnited States, Canada
-
GenesisCare USACompletedProstate AdenocarcinomaUnited States
-
Soonchunhyang University HospitalSMG-SNU Boramae Medical CenterNot yet recruitingNeoplasms | Secondary Malignant Neoplasm
-
Duke UniversityGateway for Cancer ResearchActive, not recruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Active, not recruitingPancreatic Cancer | Periampullary AdenocarcinomaUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedSarcoma | Metastatic Disease | Bony SitesUnited States
-
Mercy ResearchCompletedArteriovenous Malformations | Neurofibroma | Chordoma | Meningioma | Schwannoma | Spinal Metastases | Paragangliomas | Vertebral Metastases | Benign Spinal TumorsUnited States
-
Kantonsspital Winterthur KSWKrebsforschung Schweiz, Bern, SwitzerlandRecruitingPain | Bone Metastases | Radiation TherapySwitzerland
-
Fudan UniversityNot yet recruitingNasopharyngeal Carcinoma | Metastasis | Stereotactic Body Radiation TherapyChina
-
Peking University Third HospitalActive, not recruitingLung Cancer | Radiotherapy | Stereotactic Body Radiotherapy | FractionationChina