Head and Neck Squamous Cell CarcinomaPhase 2NCT06170710
Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC
A Phase 2 study testing Anti-PD-1 monoclonal antibody and Postoperative CCRT in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Anti-PD-1 monoclonal antibody and Postoperative CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Nov 2027
- 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
- Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion；For HPV- HNSCC：T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases
- ECOG performance score 0-1
- PD-L1 expression with CPS>1
- No contraindications to immunotherapy or chemoradiotherapy
- Adequate organ function
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- Female subject of childbearing potential should have a negative pregnancy test within 7 days prior to receiving the first dose of study medication.Female subjects of childbearing potential must be willing to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- Reproductive male subjects must agree to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- Informed consent is obtainable.
Who cannot join
- Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer
- Active infection
- Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV
- Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study
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- History of PD-1/L1 treatment
- If the subjects underwent major surgery for non-tumors, the toxicity and complications of the surgery needed to be adequately treated and the body conditions returned to normal
- Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- Other circumstances leading to the termination of the study, as determined by the investigator
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
National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Jingbo Wang, Dr., +861087787249, wangjingbo201001@163.com
About this study
Official title: Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
Read the detailed description
This open-label, randomized, controlled, phase II study will include 173 patients who have been operated for their LA SCCHN with high risk.
Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT followed by/not PD-1 antibody.
The study is designed with the general objective of demonstrating that treatment CCRT followed by PD-1 antibody is more efficient than CCRT alone.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Anti-PD-1 monoclonal antibody, Postoperative CCRT
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 monoclonal antibodyDrug
Postoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following:
Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab，200mg，Q3W or Camrelizumab，200mg，Q3W or Sintilimab，200mg，Q3W or Toripalimab，240mg，Q3W
Postoperative CCRTOther
Postoperative chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| RT+ cisplatin+Anti-PD-1 antibody | Experimental | Concurrent cisplatin-RT followed by PD-1 antibody Receives: Drug: Anti-PD-1 monoclonal antibody; Other: Postoperative CCRT |
| RT+ cisplatin | Active comparator | Concurrent cisplatin-RT Receives: Other: Postoperative CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival at year 2 (2y-DFS)
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence（including carcinoma in situ）or death from any cause.
Measured: From randomization until time of events up to 2 years
Secondary outcomes (3)
Locoregional control at year 2 (2y-LRC)
LRC defined from randomization to first radiographically or pathologically confirmed local or regional recurrence.
Measured: From randomization until time of events up to 2 years
Overall survival at year 2 (2y-OS)
Time between the date of randomization and death.
Measured: From randomization until death due to any cause, up to 2 years
Adverse events
Adverse events and serious adverse events according to CACTE 5.0.
Measured: From randomization until time of events up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2027 (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 Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingbo Wang, Dr., Principal investigator, National Cancer Cencer/Cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170710
- Sponsor's protocol ID
- 23/219-3961
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06170710
- Acronym / sponsor ID
- 23/219-3961
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 14 Dec 2023 (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.
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
Detailed description
This open-label, randomized, controlled, phase II study will include 173 patients who have been operated for their LA SCCHN with high risk.
Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT followed by/not PD-1 antibody.
The study is designed with the general objective of demonstrating that treatment CCRT followed by PD-1 antibody is more efficient than CCRT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT+ cisplatin+Anti-PD-1 antibody | Experimental | Drug: Anti-PD-1 monoclonal antibody, Other: Postoperative CCRTConcurrent cisplatin-RT followed by PD-1 antibody |
| RT+ cisplatin | Active comparator | Other: Postoperative CCRTConcurrent cisplatin-RT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion；For HPV- HNSCC：T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases
- ECOG performance score 0-1
- PD-L1 expression with CPS>1
- No contraindications to immunotherapy or chemoradiotherapy
Key exclusion criteria (10 listed)
- Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer
- Active infection
- Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV
- Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
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 |
|---|---|---|
| Anti-PD-1 monoclonal antibodyPostoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following: Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab，200mg，Q3W or Camrelizumab，200mg，Q3W or Sintilimab，200mg，Q3W or Toripalimab，240mg，Q3W | Drug | RT+ cisplatin+Anti-PD-1 antibody |
| Postoperative CCRTPostoperative chemoradiotherapy | Other | RT+ cisplatin, RT+ cisplatin+Anti-PD-1 antibody |
Primary outcome
Disease free survival at year 2 (2y-DFS)
Time frame: From randomization until time of events up to 2 years
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence（including carcinoma in situ）or death from any cause.
3 secondary outcomes
Locoregional control at year 2 (2y-LRC)
Time frame: From randomization until time of events up to 2 years
Overall survival at year 2 (2y-OS)
Time frame: From randomization until death due to any cause, up to 2 years
Adverse events
Time frame: From randomization until time of events up to 2 years
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 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Jingbo Wang, Dr. principal investigator
National Cancer Cencer/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 Anti-PD-1 monoclonal antibody and Postoperative CCRT in people with Head and Neck Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 10 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 14 Dec 2023. 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 Jingbo Wang, Dr. (+861087787249, wangjingbo201001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival at year 2 (2y-DFS) (time frame: From randomization until time of events up to 2 years). 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 14 Dec 2023.