Recurrent Head and Neck Squamous Cell CarcinomaPhase 2neo-RecurNCT07751289
Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Neoadjuvant PD-1 antibody plus chemotherapy, surgery and Adjuvant PD-1 antibody in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Yanjie Zhang, MD.
Trial summary
The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Neoadjuvant PD-1 antibody plus chemotherapy, surgery and Adjuvant PD-1 antibody
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2032
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years old (inclusive).
- Primary Tumor: Histologically or cytologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma). Patients must have previously received surgery and/or radiotherapy.
- Diagnosis: Locally recurrent or metastatic disease confirmed by pathology and/or imaging.
- Clinical Stage: T1-4a, N0-2, M0 (AJCC TNM Staging System, 8th Edition), with no evidence of distant metastasis, and the recurrent lesion is assessed as surgically resectable.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life Expectancy: Expected survival ≥ 6 months.
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- Immunotherapy: No significant contraindications to immunotherapy.
- Consent to Surgery: Willing to undergo surgical treatment.
- Adequate Organ Function:
- Hematology (without transfusion or hematopoietic growth factor support within 14 days): WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, Platelets ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
- Biochemistry: Serum albumin ≥ 3.0 g/dL (30 g/L), Total bilirubin (TBIL) ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and Creatinine ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).
- Coagulation: Adequate coagulation function defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN. For participants receiving anticoagulant therapy, PT must be within the intended therapeutic range of the anticoagulant.
- Contraception: Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must agree to use effective contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody.
- Informed Consent: The participant must voluntarily join the study, sign the informed consent form, be compliant, and be willing to cooperate with follow-up.
Who cannot join
- Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways.
- Presence of active severe autoimmune disease. Participants with conditions that are stable and do not require systemic immunosuppressive therapy are eligible, such as: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).
- Has a congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or active hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).
- Known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
- Occurrence of any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, cardiac insufficiency of NYHA Class 2 or higher, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure.
- Vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug. Inactivated virus vaccines for seasonal influenza administered via injection are permitted; however, intranasal live attenuated influenza vaccines are not permitted.
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- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of psychoactive substance abuse or drug addiction.
- Pregnant or breastfeeding women.
- Diagnosis of any other malignancy within 5 years prior to study entry, with the exception of locally treated and cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer.
- Presence of any other severe physical or mental illness or laboratory abnormality that may increase the risk of participating in the study, interfere with the study results, or render the participant unsuitable for participation in the study, as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anti-PD-1 Therapy in Locoregionally Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma: A Multicenter, Randomized Controlled Clinical Trial
The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.
The main questions it aims to answer are:
Read more
Does perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?
Researchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.
Participants will:
Be randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.
Visit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.
Be followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.
- Being tested
- Neoadjuvant PD-1 antibody plus chemotherapy, surgery, Adjuvant PD-1 antibody
- Keywords
- PD-1 inhibitor, Randomized Controlled Trial, Neoadjuvant Chemoimmunotherapy, Head and Neck Squamous Cell Carcinoma, Locally Recurrent Disease
- 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.
Neoadjuvant PD-1 antibody plus chemotherapyDrug
Administered once every 3 weeks for 2 to 4 cycles before surgery
surgeryProcedure or surgery
Surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated.
Adjuvant PD-1 antibodyDrug
Administered postoperatively every 3 weeks for up to 15 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy | Experimental | Participants will receive 2-4 cycles of neoadjuvant PD-1 antibody plus chemotherapy every 3 weeks, followed by surgery and postoperative radiotherapy or chemoradiotherapy as clinically indicated. PD-1 antibody will be continued as adjuvant therapy for up to 15 cycles. Receives: Drug: Neoadjuvant PD-1 antibody plus chemotherapy; Procedure: surgery; Drug: Adjuvant PD-1 antibody |
| Upfront Surgery | Active comparator | Participants will undergo upfront surgery with or without postoperative radiotherapy or chemoradiotherapy. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
Measured: 2 years after randomization
Secondary outcomes (7)
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive. OS will be estimated using the Kaplan-Meier method. The planned primary OS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
Measured: 2 years after randomization
5-Year Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment or at 5 years after randomization, whichever occurs first. EFS will be estimated using the Kaplan-Meier method.
Measured: 5 years after randomization
5-Year Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive or at 5 years after randomization, whichever occurs first. OS will be estimated using the Kaplan-Meier method.
Measured: 5 years after randomization
Adverse Events and Serious Adverse Events
The number and percentage of participants with adverse events and serious adverse events will be summarized. Events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Summaries will include event type, incidence, severity, onset and resolution dates, seriousness, relationship to study treatment, and outcome.
Measured: From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.
Pathologic Complete Response (pCR) Rate
The percentage of participants receiving neoadjuvant treatment who undergo surgery and have no residual viable tumor cells in either the resected primary tumor or any sampled regional lymph node, corresponding to ypT0N0, based on postoperative pathological assessment.
Measured: Within 2 weeks after surgery
Major Pathologic Response (MPR) Rate
The percentage of participants receiving neoadjuvant treatment who undergo surgery and have 10% or less residual viable tumor in the resected specimen. MPR is defined as a residual viable tumor area divided by the total tumor bed area of 10% or less, as determined by blinded review by the pathology review committee.
Measured: Within 2 weeks after surgery
Objective Response Rate (ORR)
The percentage of participants receiving neoadjuvant treatment who achieve a best overall radiographic response of complete response or partial response, as assessed according to Response Evaluation Criteria in Solid Tumors, version 1.1.
Measured: At the preoperative tumor assessment after completion of 2 to 4 cycles of neoadjuvant treatment (each cycle is 21 days; approximately 6 to 12 weeks after initiation of neoadjuvant treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck Squamous Cell 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanjie Zhang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanjie Zhang, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751289
- Sponsor's protocol ID
- neo-Recur
- Acronym
- neo-Recur
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Therapy in Locoregionally Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma: A Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07751289
- Acronym / sponsor ID
- neo-Recur / neo-Recur
- Keywords
- PD-1 inhibitor, Randomized Controlled Trial, Neoadjuvant Chemoimmunotherapy, Head and Neck Squamous Cell Carcinoma, Locally Recurrent Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Yanjie Zhang, MDUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 7 Aug 2026 (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 goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.
The main questions it aims to answer are:
Does perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?
Researchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.
Participants will:
Be randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.
Visit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.
Be followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy | Experimental | Drug: Neoadjuvant PD-1 antibody plus chemotherapy, Procedure: surgery, Drug: Adjuvant PD-1 antibodyParticipants will receive 2-4 cycles of neoadjuvant PD-1 antibody plus chemotherapy every 3 weeks, followed by surgery and postoperative radiotherapy or chemoradiotherapy as clinically indicated. PD-1 antibody will be continued as adjuvant therapy for up to 15 cycles. |
| Upfront Surgery | Active comparator | Procedure: surgeryParticipants will undergo upfront surgery with or without postoperative radiotherapy or chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age: 18 to 80 years old (inclusive).
- Primary Tumor: Histologically or cytologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma). Patients must have previously received surgery and/or radiotherapy.
- Diagnosis: Locally recurrent or metastatic disease confirmed by pathology and/or imaging.
- Clinical Stage: T1-4a, N0-2, M0 (AJCC TNM Staging System, 8th Edition), with no evidence of distant metastasis, and the recurrent lesion is assessed as surgically resectable.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (11 listed)
- Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways.
- Presence of active severe autoimmune disease. Participants with conditions that are stable and do not require systemic immunosuppressive therapy are eligible, such as: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).
- Has a congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or active hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).
- Known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
- Occurrence of any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, cardiac insufficiency of NYHA Class 2 or higher, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure.
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 |
|---|---|---|
| Neoadjuvant PD-1 antibody plus chemotherapyAdministered once every 3 weeks for 2 to 4 cycles before surgery | Drug | Neoadjuvant Chemoimmunotherapy |
| surgerySurgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated. | Procedure or surgery | Neoadjuvant Chemoimmunotherapy, Upfront Surgery |
| Adjuvant PD-1 antibodyAdministered postoperatively every 3 weeks for up to 15 cycles. | Drug | Neoadjuvant Chemoimmunotherapy |
Primary outcome
Event-Free Survival (EFS)
Time frame: 2 years after randomization
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
7 secondary outcomes
Overall Survival (OS)
Time frame: 2 years after randomization
5-Year Event-Free Survival (EFS)
Time frame: 5 years after randomization
5-Year Overall Survival (OS)
Time frame: 5 years after randomization
Adverse Events and Serious Adverse Events
Time frame: From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.
Pathologic Complete Response (pCR) Rate
Time frame: Within 2 weeks after surgery
Major Pathologic Response (MPR) Rate
Time frame: Within 2 weeks after surgery
Objective Response Rate (ORR)
Time frame: At the preoperative tumor assessment after completion of 2 to 4 cycles of neoadjuvant treatment (each cycle is 21 days; approximately 6 to 12 weeks after initiation of neoadjuvant treatment).
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 7 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant PD-1 antibody plus chemotherapy, surgery and Adjuvant PD-1 antibody in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Yanjie Zhang, MD.
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 14 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yanjie Zhang, Doctor of Medicine (021-23271699, zhangyanjie2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: 2 years after randomization). 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 7 Aug 2026.