Head and Neck Squamous CarcinomaPhase 2NCT06306846
Neoadjuvant SBRT in Localized Advanced HNSCC
A Phase 2 study testing SBRT+immunochemotherpy, Immunochemotherapy and cetuximab+immunochemotharpy in people with Head and Neck Squamous Carcinoma, run by Jiang Feng at 1 site in China.
Trial summary
The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Carcinoma
- What is being tested?
- SBRT+immunochemotherpy, Immunochemotherapy and cetuximab+immunochemotharpy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Feng Jiang, MD, 0086-571-88128202, jiangfeng@zjcc.org.cn
About this study
Official title: Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.
Read the detailed description
locally advanced HNSCC patients would receive PD-1 antibody and chemotherapy with or without SBRT covering GTV of primary disease and metastatic nodes , followed by surgery. pathological response was measured .Neoadjuvant PD-1 antibody and chemotherapy with certuxmab was also tested
- Conditions
- Head and Neck Squamous Carcinoma
- Being tested
- SBRT+immunochemotherpy, Immunochemotherapy, cetuximab+immunochemotharpy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT+immunochemotherpyRadiation
Also called immunochemotherapy
SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy
ImmunochemotherapyDrug
PD-1 monoclonal antibody and TP chemotheapy
cetuximab+immunochemotharpyDrug
PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: SBRT+immunochemotherpy |
| control | 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. Receives: Drug: Immunochemotherapy |
| Cetuximab+immunochemo | 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. Receives: Drug: cetuximab+immunochemotharpy |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathology response (MPR)
major pathology response
Measured: 4-6 weeks after the end of the neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiang Feng, Zhejiang Cancer Hospital
- Investigators
- feng Jiang, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306846
- Sponsor's protocol ID
- 11235794
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06306846
- Acronym / sponsor ID
- 11235794
- Conditions
- Head and Neck Squamous Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Jiang FengUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.
Detailed description
locally advanced HNSCC patients would receive PD-1 antibody and chemotherapy with or without SBRT covering GTV of primary disease and metastatic nodes , followed by surgery. pathological response was measured .Neoadjuvant PD-1 antibody and chemotherapy with certuxmab was also tested
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Radiation: SBRT+immunochemotherpyStep 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. |
| control | Active comparator | Drug: ImmunochemotherapyStep 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. |
| Cetuximab+immunochemo | Active comparator | Drug: cetuximab+immunochemotharpyStep 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT+immunochemotherpyAlso: immunochemotherapySBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy | Radiation | experimental |
| ImmunochemotherapyPD-1 monoclonal antibody and TP chemotheapy | Drug | control |
| cetuximab+immunochemotharpyPD-1 monoclonal antibody and TP chemotheapy combined with cetuximab | Drug | Cetuximab+immunochemo |
Primary outcome
major pathology response (MPR)
Time frame: 4-6 weeks after the end of the neoadjuvant therapy
major pathology response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
feng Jiang, MD principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT+immunochemotherpy, Immunochemotherapy and cetuximab+immunochemotharpy in people with Head and Neck Squamous Carcinoma, run by Jiang Feng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Jiang, MD (0086-571-88128202, jiangfeng@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathology response (MPR) (time frame: 4-6 weeks after the end of the neoadjuvant therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.